Challenges and benefits of EDC adoption

Apr 26, 2013 by Clinovo    No Comments    Posted under: EDC, Trends

Clinical research is one of the most expensive areas of drug development. Bringing an approved new drug from initial private investment to a patient takes over 13 years and $1.3 billion, or an average of $146 million per year.¹

Industry data shows clinical trials costs are growing across all development phases. A 2011 report, Clinical Operations: Benchmarking Per-Patient Costs, Staffing and Adaptive Design by Cutting Edge Information, tracked costs for 100 trials across multiple therapeutic areas finding that per-patient clinical trial costs rose an average 70% from 2008 to 2011.² The largest increases occurred in Phase IIIa and Phase IIIb. Phase I trials are also suffering from cost inflation, with per-patient costs increasing by an average 46% over the same time period.³

Electronic Data Capture (EDC), which collects clinical trial data electronically rather than on paper, is becoming an increasingly popular solution for streamlining data processing. This white paper will review benefits that EDC brings, extending beyond, and contributing to, cost-efficiency. It will also discuss challenges and limitations that sponsor companies can expect when implementing EDC solutions in clinical research.

Key benefits of Electronic Data Capture

1. Cost-saving: Forrester Research analyzed cost-savings to Novartis, which has utilized a customized open-source EDC system for over 400 clinical trials. For a 12-month Phase II clinical trial with 20 sites and 10 patients per site, the operational savings were substantial: $347,600.⁴

Figure 1. Forrester Research Paper versus EDC cost comparison.⁵

The cost of the clinical trial was reduced from $732,000 to $384,000 thanks to remote monitoring, fewer site visits, shorter patient recruitment times, reduction (or elimination) of printing costs, faster data entry, and lower data cleaning costs.⁶ Visit-related costs were reduced by 50%, data cleaning costs by 80%, and all other operational expenses by 32%.⁷

Overall, Novartis claimed a savings of approximately $17 million by no longer needing to print CRFs on NCR paper, a necessity in paper-based trials, which represented $42,500 per Novartis study analyzed.⁸ If we consider that printing costs run as high as $100 per casebook, a study with 500 patients would cost up to an estimated $50,000 prior to factoring in staffing costs for casebook preparation, without accounting for shipping.

2. Time-saving: Single data entry—which replaces the completion of paper CRFs followed by double data entry—remote monitoring, and reduction in the number of queries each save a considerable amount of time. Overall, they have been calculated to reduce the duration of clinical development by up to 30%.⁹

It is critical to note that the most significant time-savings occur during database lock. It has been shown that, when it is time for database lock, there is less missing data and fewer errors and queries with EDC than with paper-based systems. As shown in the table below, database lock can take as long as nine days with paper, whereas database lock is performed in only one day with an EDC system.

Figure 2. Time savings.

3. Cleaner data and reduced queries: EDC adoption leads to a dramatic reduction in the types of data errors found in paper-based CRF studies, such as out-of-range values and missing data. In addition, errors can be detected and corrected much earlier in the clinical trial with EDC than with paper-based systems that can only rely on ad hoc mid-study analysis. EDC edit checks are automatic and visible at the time of entry and are therefore resolved immediately, resulting in cleaner data at time of entry in database.

A case study led by Applied Clinical Trials compared a paper query management system with an EDC system using edit checks and found a 65% reduction in the number of queries.¹⁰

Figure 3. Reduction of the number of queries.¹¹

4. Traceability: Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) is the United States Federal Regulation which applies to electronic records and electronic signatures in clinical systems.¹² EDC systems must track all data changes in audit trails in order to be 21 CFR Part 11 compliant. Vendors must also plan for disaster recovery and analyze and remedy potential risks. It is critical to note that answering FDA reviewers’ questions is made easier by EDC systems as they can track any changes automatically.

5. Simplified monitoring: Remote monitoring enabled by EDC systems drastically lowers the cost of monitor visits. EDC enables early identification of discrepancies or data entry errors, minimizing the time spent by monitors at sites. Estimating that a visit can cost up to $3,000, the total savings for a study with 20 sites can reach $60,000.

6. Reduced data entry: With paper-based systems, clinical data must first be written on paper and then double-data entered into a central system, which is a time-consuming and error-prone process. Electronic Data Capture’s Impact on Late Phase Research by Dr. Hugh P. Levaux claims that, when considering manual double-data entry costs can be as high as $3 per page, a 100-page casebook can cost as much as $300. These figures translate to a cost of $150,000 for a 500-patient study.¹³ EDC applications necessitate only single-data entry since data entry occurs directly at the site and is the equivalent of CRF completion on paper.

7. Reactivity: Some EDC systems provide real-time alerts and reports, giving decision makers instant access to critical data. ClinCapture by Clinovo recently introduced LiveReports^TM to provide a real-time overview of the clinical trial. Real-time reports enable decision makers to be more proactive in identifying bottlenecks such as late sites, and to be more reactive to data to ensure patient safety.

Ultimately, EDC systems enable sponsors to make efficacy and/or safety determinations earlier in the drug development process. EDC enables pharmaceutical, biotechnology, and medical device industries to focus on the development of the best drug, biologic, or device candidates that will most benefit patients, saving time and millions of dollars in drug development.

8. Reusability: A characteristic of EDC is the ability to reuse the system in future studies which lowers the cost of EDC adoption in the long run. Once forms and their associated edit checks are created, they can be stored in a library and reused for an infinite number of studies. In a case study from Clinovo, a leading global technology medical device company was looking to efficiently manage large amounts of data while staying on-time and on-budget.¹⁴ Clinovo trained the sponsor’s staff to build its studies on the open-source EDC system ClinCapture, enabling the sponsor to customize the ClinCapture platform and roll out nine additional studies themselves. In addition, the sponsor was able to host the system in-house, thereby avoiding vendor lock-in and retaining full control over their clinical data.

9. Mid-study changes: EDC systems make mid-study changes such as the addition of new fields in a Case Report Form (CRF) much smoother than do paper-based studies. Some EDC systems support CRF versioning to automatically update all CRFs in selected sites in just a few seconds.

10. Patient Safety: Improved data quality, better reactivity, and reduction in study time themselves contribute to the faster delivery of better medications. Some specific EDC features have an even bigger impact: faster notification of adverse events, for example, can help with earlier and better decision-making, potentially saving hundreds or thousands of patients from exposure to unsafe medication.

Limits and difficulties of EDC adoption

Despite the tangible benefits of Electronic Data Capture, the adoption of EDC systems has remained slow in some segments of clinical research. Only 40% of Phase I clinical trials had adopted EDC by the end of 2012.

Clinical trial experts suggest this slow adoption is explained by the high cost of proprietary EDC systems and by the structural changes and learning curves incurred by sponsor companies when implementing an EDC system. Some attribute low adoption rates to negative impressions of early EDC systems based on poor design and limited performance.

There is a common perception that paper-based studies are faster and less expensive to implement than are EDC studies. It is undoubtedly true that studies can be started faster on paper. But data shows that their overall duration is as much as 30% longer on average.¹⁵

EDC vendors are making an effort to minimize the study-build time by leveraging reusability and automation. It is now possible to deploy a full EDC study in days rather than the weeks or months historically, assuming study form reusability.

The initial cost of EDC is also a major determent to its adoption, especially for preclinical or Phase I trials with lower budgets. The most significant costs are incurred when hiring vendor(s), assigning clinical and data management experts to interface with programmers, and setting up internal computer systems, including the purchase of hardware and software. Following these initial setup phases, subsequent study costs for each new clinical trial can become marginal, leaving mostly fixed annual fees for system maintenance, including optional hosting fees.

Finally, data privacy and security is also a major concern among trial investigators. A study by Silico Research shows that investigators cite security and confidentiality as key concerns when conducting EDC-based clinical trials.¹⁶ It is essential to select EDC vendors who thoroughly follow regulations and offer secure hosting services with data redundancy ensuring full disaster recovery.

Figure 4. Trial investigators concerns on EDC-based clinical trials.¹⁷

Among other concerns, sponsors also worry about the steep learning curve and heavy training needed to switch to an EDC system. The implementation of an EDC system drastically changes the structure and the processes within a sponsor organization. EDC vendors are aware of these difficulties and are focusing on improving EDC systems’ ease-of-use. Vendors are also putting an emphasis on training sessions for end users as well as on ensuring reactive support services.

Moreover, one can observe standardization in the user interface guided by consensus-based collaborative standards like CDISC/CDASH, allowing for consistent user experience across vendors and studies and thereby requiring less training to adapt to new study screens.

Conclusion: Planning EDC deployment, a key success factor

A potential steep learning curve for clinical research teams, structural changes in organizations, and perceived high cost of EDC implementation are some of the legitimate reasons to hesitate before adopting EDC. However, considerable time- and cost-savings, along with drastic data quality improvement outweigh these difficulties.

It is necessary for sponsors to put controls in place to ensure data quality and integrity throughout their clinical trials. This can and is done with paper-based clinical studies, but often with unintended negative consequences, including delay and looping in the data entry process. With EDC, edit checks are integrated from the start and are seamlessly activated during data entry, ensuring that the sites, which are responsible for providing study data, can address most issues on the spot.

In order to fully benefit from EDC systems, it is critical for sponsors to plan ahead. Most importantly, planning must be carried out prior to study build. Data entry screens, online edit check specifications, and the annotated case report form (aCRF) must be implemented before the study goes live.

Though the process changes as it evolves, Electronic Data Capture brings complete and up-front integration of the trial design and setup to the different operational groups involved, including Clinical Operations, Clinical Data Management, and Biostatistics, thus ensuring not only that the data entry process is easy and well-customized for the clinical sites, but also that the final database exports will be fully compliant and meet analysis requirements.

Olivier Roth, Marketing and Communication Coordinator, Clinovo

References

1. Herper, M. The Truly Staggering Cost of Inventing New Drugs. Forbes website. http://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/. February 2012. Accessed April 9, 2013.
2. Per-Patient Clinical Trial Costs Rise 70% in Three Years. Cutting Edge Information website. http://www.cuttingedgeinfo.com/2011/per-patient-clinical-trial-costs/. July 2011. Accessed April 8, 2013.
3. Ibid.
4. Peachey J, Spink C, Fraser H, Henderson S. The eClinical equation: Part 1: Electronic Data Capture. IBM Global Business Services: IBM Institute for Business Value. 2005; 3. http://www-05.ibm.com/de/healthcare/literature/eclinical-equation-1-lang.pdf. Accessed April 8, 2013.
5. Ibid.
6. Ibid.
7. Ibid.
8. Ibid, 3-4.
9. Green, J. Realising the value proposition of EDC. Innovations in Clinical Trials. September 2003; 13. http://www.iptonline.com/articles/public/ICTTWO12NoPrint.pdf. Accessed April 8, 2013.
10. Mitchel J, You J, Lau A, Kim Y. Paper vs. Web: A Tale of Three Trials. Applied Clinical Trials: Internet Insight Section. August 2001; 1. http://www.medchannels.com/pdfs/whitepapers/ACTArticle.pdf. Accessed April 8, 2013.
11. Ibid.
12. Part 11, Electronic Records; Electronic Signatures – Scope and Application. U.S. Food and Drug Administration website. http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm. March 23, 2009. Accessed April 9, 2013.
13. Levaux, H. Electronic Data Capture’s Impact on Late Phase Research. Business Briefing: Pharmatech. 2004. http://www.touchbriefings.com/pdf/890/PT04_Ninaza.pdf. Accessed April 8, 2013.
14. Clinovo Case Study: Open Source EDC Unmatched Cost-efficiency. Clinovo website. August 28, 2012. http://www.clinovo.com/userfiles/clinovo-open-source-edc-unmatched-cost-efficiency.pdf. Accessed April 8, 2013.
15. Green, J. Realising the value proposition of EDC. Innovations in Clinical Trials. September 2003; 13. http://www.iptonline.com/articles/public/ICTTWO12NoPrint.pdf. Accessed April 8, 2013.
16. Peachey J, et al. The eClinical equation: Part 1: Electronic Data Capture. IBM Global Business Services: IBM Institute for Business Value.  2005; 9. http://www-05.ibm.com/de/healthcare/literature/eclinical-equation-1-lang.pdf. Accessed April 8, 2013.
17. Ibid.

Thank you Note

• Jean Maupas, Director of Operations, Clinovo
• Dave Alderson, Senior Director of Sales, Clinovo
• Anil Kishan, Marketing Assistant, Clinovo
• Maxwell Love, Business Development, Clinovo

Game-changing predictive solution for clinical research

Oct 4, 2012 by Clinovo    2 Comments    Posted under: Events, Trends

I wanted to share the following article with you, borrowed from the Drug, Discovery & Development online magazine:

Drug development programs today have a 5% to 10% probability of success. Almost half of the failures are due to drug safety issues found very late in the clinical development process. The lack of improvement in outcomes, despite advances in technology and the near doubling of pharmaceutical R&D expenditures, highlights the need for novel approaches to drug development.

Currently, the identification of efficacy and safety risks for a lead compound primarily uses cell line and in vivo studies. Unfortunately, these experimental systems are black boxes that offer limited visibility into selected phenotypes and biomarkers and very little insight into the effects of a compound on important physiological pathways. Due to this lack of transparency into pathway effects, it is difficult to generate insights into system-level changes in the physiological network. This is often a reason for potential oversight of toxicity issues and incorrect assessment of efficacy.

In the era of molecularly targeted drugs that affect specific targets and pathways, developers must have insights into the off-pathway effects of drug candidates. Use of predictive methodologies that emulate human physiology to test the impact of the drug candidate prior to moving the drug into clinical testing is crucial to improve the drug development success rate. By predicting clinical outcomes early on, the success rate of drug development can dramatically be improved.

The development of a predictive system emulating disease physiology is feasible because of the massive amount of published reductionist information on signaling and metabolic pathway components and “omics” data coupled with advances in mathematical techniques and computing power. Coupling the massive library of published data to computing power enables researchers to connect the dots in a way not possible before and, therefore, predict clinical outcomes early on.

Predictive models offer the promise of predicting clinical outcomes early in the development process and give the ability to rationally construct efficacious therapies with lower potential for side effects. The large availability of data and information on the components of the biological networks and interactions has enabled the creation of such systems. This approach provides transparency to manipulate different pathways in the network and assay intermediate and endpoint biomarkers and disease phenotypes. The key criterion for deployment of such an approach is extensive validation of predictions with experimental studies.

About the author - Pradeep Fernandes has a background in semiconductor engineering and has applied the engineering approaches and technologies to create the Cellworks technology platforms. Shireen Vali has a background in molecular and cellular neurobiology and has worked extensively in developing the disease networks underlying complex multi-phenotype disorders.

Olivier ROTH
Marketing & Communication Coordinator at Clinovo

The Changing Role of the Clinical Data Manager (CDM)

Sep 27, 2012 by Clinovo    No Comments    Posted under: Trends

How is the growing adoption of EDC affecting CDMs?  Is processes automation easing or threatening the work of CDMs? How is systems integration changing the required skillsets of CDMs and how to adapt? The Clinical Data Manager today: Emergency-based fireman or provident manager?

The evolution of technologies in clinical trials leads to a redefinition of the CDM role. The fast-pace adoption of EDC systems reduces the overhead of manual cleaning tasks and time-consuming back-and-forths. As a result, CDMs are asked to handle a far greater volume of complex data streams. They are also expected to spot and solve problems at earlier stages, and to collaborate with statisticians and site monitors to set specifications for validation and edit checks prior to data collection.CDMs are becoming a key cross-road and take on the role of information providers in their organization with the sponsor and sites. They need to understand the entire clinical development spectrum and how data fits.

Today, Clinical Data Managers are not only Clinical Data Managers, they can also be projects managers, programmers and in some cases medical managers, quality or regulatory experts. This inflation of competencies lead to the development of a new generation of cross-trained CDMs, eager to match their skillset with the job market expectations. CDMs have been taking on new responsibilities within their organization and benefit from additional professional opportunities.

Do you want to learn more and react on the topic? On October 24th, Clinovo will broadcast a free webinar on the Changing Role of the Clinical Data Manager. This webinar will benefit CDMs but also industry professionals looking for ways to understand and benefit from upcoming trends in the Clinical Data Management field. The presentation will be followed by an open discussion on the topic.

Click here to register now!

Mobile Devices Pave the Path for Clinical Research Evolution

Sep 19, 2012 by Clinovo    No Comments    Posted under: New Technologies, Trends

Clinical trial sponsors looking to stay at the forefront of efficiency and accuracy should consider whether they are making the best use of the growing trend of access to clinical data on mobile devices. From the secure sharing of electronic patient reported outcome (ePRO) data, to creating more flexible clinical data management, mobile technology has the potential to improve processes across the clinical research process. In many cases, sponsors are already seeing the benefits – including real-time alerting capabilities and increased efficiencies – of incorporating mobile technology in their research process.

Real-time results – delivered to the right people at the right moment

Real-time alerting can dramatically improve a trial’s overall success rate. Alerts can be configured to automatically send an email or text message to a mobile device when a pre-specified event occurs, such as when a serious adverse event (SAE) is entered into the system. It is important that alerts notify mobile devices; most people are not always logged into their computer workstation, but many keep their smartphone or tablet close by. This helps ensure that all relevant stakeholders are informed as quickly as possible when their action is required. For example, if a patient in Sweden reports symptoms via their iPad after intake of Drug X, their information can be instantly analyzed in California, where a data manager will be notified that he or she needs to take appropriate next steps, which may include alerting sites across the globe to suspend the use of Drug X. With the use real-time notifications delivered through mobile devices and the ability to act upon this feedback from any web-enabled device, response times can be reduced from days or weeks to hours or minutes, giving clinical teams the opportunity to address problems before they put a study in jeopardy.

Consumer-based efficiency – taking advantage of familiar technology

Increasing trial efficiency and correctness are common requirements for CROs and trial managers when implementing new clinical trial technologies. Luckily, mobile devices and their efficiency benefits can be easily introduced into the research process without costly hardware investments or extensive user training. Most trial participants and managers currently utilize mobile devices in their everyday life, so the functionality is already available. Because participants are using a technology they already understand, it becomes easy for them to enter data directly. In addition, trial participants will be more likely to engage with tools they’re already familiar with, enabling increased accuracy and improved reporting. And because of the connectivity of mobile devices, it is easy for trial managers to retrieve data from patients without costly delays.

Data security concerns – succeed with caution

In order to make mobile capabilities a research reality, we can’t ignore the possibility of security threats and regulatory concerns. However, mobile software can be very secure if written properly, and the clinical trial industry can benefit from the great strides other industries such as online banking have made in mobile security. Similarly, regulatory concerns can also be addressed by ensuring mobile software is fully Title 21 CFR Part 11 compliance. Data security is a risk in any electronic platform, but when addressed carefully, its risks need not outweigh the vast benefits that electronic technologies provide.

Propelling into a mobile-charged future

As the clinical industry becomes more dependent on technology, waiting for results or data batches to be complete will no longer be acceptable or considered the norm. The ability to increase efficiency, analyze live data and implement results immediately demonstrates collectively the key benefits of utilizing mobile devices in clinical trials. Taking advantage of new and innovative technologies is a key to the future of clinical trials, and mobile capabilities will pave the way.

Rick Morrison
CEO, Comprehend Systems

Rick Morrison is the co-founder and chief executive officer of Comprehend Systems. Prior to founding Comprehend Systems, Rick served as the chief technology officer of an internet-based data aggregator, where he was responsible for product development and operations. Rick has over a decade of experience writing software for clinical trials, including tools that are now used by the FDA and top pharma. Rick holds a bachelor’s degree in computer science from Carnegie Mellon University.

TechTrainings: Improve your skillset

Aug 28, 2012 by Clinovo    No Comments    Posted under: Events

It is a very exciting time for Clinovo! We are now officially launching our TechTrainings, a new opportunity for a successful career in the clinical trial industry. These hands-on classes enable entry-level or already experienced clinical trial professionals to improve their skillset. Real-world case studies were designed with 10+ years experienced professionals to help our students reach the next step in their career.

Please visit this page to check out the first session 101 Clinical SAS Programming by Jennifer Kang, Senior Statistician at the Palo Alto Medical Foundation Research Institute (PAMFRI). We know it takes time and effort to “go back to school” so we came up with a convenient format: one 3-hour class per week during 10 weeks. If you happen to know anyone interested in learning SAS, note that you can win a $50 giftcard and your friend can benefit from a discounted registration.

Some of our readers and followers expressed the need for other trainings in the future. If you think of another major topic for which Clinovo’s expertise is needed (CDM, EDC, CDISC, clinical trial design, etc.) feel free to comment this article.

Olivier Roth
Marketing & Communication Coordinator, lead for Clinovo TechTrainings.

Pioneering Cloud Computing for Clinical Trials

Aug 13, 2012 by Clinovo    No Comments    Posted under: New Technologies, Trends

The cloud: A new paradigm

The cloud generated $36.1 billion dollars in 2011 and is expected to reach $72.8 billion by 2015 according to a recent IDC study.  With a CAGR of 21% per year from 2011 to 2015, the cloud is growing three times faster than traditional IT infrastructures. It is nowadays a commonly known revolution, yet very few people grasp the nuances and the potential behind this term. In simple words, the cloud turns everything into easily accessible and affordable services, unleashing unmatched potentials for organizations and individuals.

Defining the Cloud

The cloud is the ability to access value-added services from anywhere at any time with a level of simplicity, flexibility and cost efficiency never met before. The cloud provides on demand access to software/applications, platforms and infrastructures commonly known as:

- Software-as-a-Service (SaaS) such as web hosting services, collaborative or CRM applications such as the well-known Salesforce.com.

- Platform-as-a-Service (PaaS), providing developers the tools to develop their own applications such as databases, operating systems, etc. without any initial costly IT investment in hardware. For example Google’s App Engine is a PaaS enabling developers to create new applications.

- Infrastructure-as-a-Service (IaaS) enables access to computer infrastructures such as servers, data-centers and network equipment, once again without any heavy initial investment. This type of cloud service is often used by organizations that have the IT expertise to manage their IT requirements but not the infrastructure itself. For example, Amazon’s Elastic Compute Cloud (EC2) provides resizable compute capacity to make web-scale computing easier without the need for CAPEX.

Those three categories are called “services” in the sense that users access, subscribe, use, monitor them on an on-demand and pay-as-you-go basis. The user can monitor the Service Level Agreement (SLA) he signed for, submit tickets if necessary, look at its IT usage bill on its own, without any human interaction. The cloud is thus a very automated, elastic and cost-efficient environment.

This level of autonomy is possible thanks to processes automation: Workflows are automatically processed in the cloud without human intervention. The advantage of process automation is cost-efficiency since less IT hours are billed. Today, around 70% of IT budgets are spent on maintaining the infrastructure, leaving only 30% for new projects.  This tends to frustrate departmental managers who see their projected queued, sometimes for years.  The cloud provides an immediate and cost effective solution while empowering these managers.

Clouds rather than Cloud

Traditionally the cloud is split into four types:

Read more about Clinovo cloud-based hosting services

Cloud technology in the life science industry 

Clinical trial professionals already use public clouds but mostly for administrative, IT, marketing or sales purposes (such as Google Drive, any document sharing system or CRM tools) but very few of the cloud services are directly related to life science.

Although cloud-based systems are gaining momentum in almost all the industries, the adoption rates for this innovative technology remain low in the life science industry. Some IT vendors in clinical trials such as Medidata Rave are arguing they are offering cloud services, whereas their services are neither self-service nor on a pay-as-you-go basis.  This is not uncommon; many companies exploit the cloud marketing buzz, yet provide services that are not self-service, automated, flexible nor cost-efficient.

In clinical trials, cloud technologies are a new opportunity to lower skyrocketing costs. Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) or ePRO systems would be configured and implemented at a much faster pace and at a much lower cost. In January 2012, Forbes calculated the average cost of bringing a new drug to market at $1.3 billion (at times $4B to $11B for big pharmaceutical companies), this calculation takes failed drug application in account.

Thanks to the always-on and automated properties of the cloud, drug development cost is bound to decrease since clinical trials will be started and ended faster than ever before.

Upcoming challenges

One of the major concerns of pioneering cloud computing for the healthcare industry is compliancy. Pharmaceutical companies must ensure that the cloud service providers they use follow GCP as guided by 21 CFR Part 11 regulation, to ensure the system is fit for its intended use;  including IP/IQ (Installation protocol and qualification), OQ (Operation qualification) and PQ (Performance Qualification).  Here are some tips about validating a clinical application in the cloud:

• You must have an installation protocol to install the application into the cloud; as well as for every minor and major version upgrade.

• In a public cloud you cannot have an installation protocol for installation of the hardware and OS images.  More and more auditors understand and accept this is a limitation of the cloud.  Do check with your QA department, if in doubt.

• You must provide test and production environments for each application in the cloud.

• You must test backup and restore of all production applications.

• It is a good idea to test your disaster recovery procedures.  You may need the cooperation of your cloud provider to simulate a disaster for you.

• Validation of the application must take place in the cloud and you must use the same documentation and methods as if the application was running on a local server.

Since clinical trials are more and more international, there is also a need to ensure that local regulations are followed. For example it is essential to know where the data is hosted. Indeed some countries require the clinical data to be hosted in the actual country of the clinical trial. For example, if a pharmaceutical company runs a clinical trial both in the US and in Japan, the Japanese data must be hosted in Japan. This regulation should be taken in consideration while implementing a global cloud-based clinical system.

Even though the cloud is promising autonomy, flexibility and cost-efficiency for pharmaceutical companies, there is a need for experts to ensure that the transition to cloud-based services for clinical trials is made in a safe and compliant manner. IT and life science are two very different areas of expertise, so it is critical to take the time to choose a vendor that has proved its worth in both area and that can guide you through this new technology.

Ultimately, the cloud technology will revolutionize the healthcare and life science industries, enabling pharmaceutical companies to bring their drug to patients faster at a lower cost.

At Clinovo, we pride ourselves to seek and bring the most innovative technologies and apply them to the life science industry to streamline clinical trials. Our team is composed of experts in both the IT industry and the life science industry

Marc Desgrousilliers, Chief Technology Officer at Clinovo

Olivier Roth, Marketing & Communication Coordinator

Dealing with the FDA today

Jul 17, 2012 by Clinovo    No Comments    Posted under: Best Practices, Best-Practices

The FDA’s mission is to protect public health by assuring “the safety, efficacy and security” of drugs. Indeed, the FDA has the tremendous challenge of ensuring sponsor companies deliver efficient treatments to patients while meeting the highest possible safety requirements.  FDA reviewers always need to thoroughly weight risks versus benefits. This sometimes has dramatic consequences: The FDA admits that in the United States 100,000 people die every single year taking FDA-approved pharmaceutical drugs. In addition to that, two million people a year suffer from serious adverse events, which include stroke, heart attack, and permanent neurological damage.

The FDA is increasing efforts to improve patient safety and identify potential side effects. It is more and more demanding with healthcare companies, trying to ensure qualified processes are in place . Indeed, while the number of FDA approvals per 1,000 US-based clinical trials has declined from 7.5 in 2004 to 3.1 in 2010, industry experts are facing increased complexity and cost when managing clinical trials. A 2010 PhArma report argues that between 2000 and 2007, the median number of procedures per clinical trial increased by 49%.

For a drug or a medical device, everything starts or ends one day in the walls of the Food and Drug Administration. What make the difference between failure and success are your clinical data and the way you deal with the FDA. This article intends to help you understand the secrets behind a successful FDA submission.

Provide regulatory compliant data

One of the new FDA expectations includes using standard format for clinical data for their submission. The FDA is thus gradually implementing CDISC standards. CDISC® (Clinical Data Interchange Standards Consortium) established these data standards to speed up data-review and improve clinical data exchange, storage and archival. CDISC standards have been acknowledged as recognized standards by the FDA for years now. They are gaining momentum and undoubtedly are an asset to accelerate the FDA review process. By 2016, CDISC standards are expected to be mandatory for any drug submission.

Understand and follow the FDA’s transformation

Staying up-to-date on any new initiatives is fundamental in order to always anticipate FDA expectations. The FDA is adapting to therapeutic-based clinical trials or personalized medicine. On the same note, the rise of orphan drugs forces the FDA to develop specific and shortened review processes. The FDA is continuously adapting to these life sciences developments. Christine Conroy, Vice President of Regulatory Affairs and GCP compliance at Affymax, points out that with the growing number of very particular compounds and patient-specific therapies, it has become sometimes difficult to provide data the FDA asks. The FDA sometimes lack experience in new fields such as biomarkers. Indeed, there is no reference point as everything is new, so it happens that the FDA brings up issues not always relevant in that field.

Find creative study design strategies to meet your endpoint

Small companies often lack financial or human resources to oversee CRO activities and analyze the quality of the data. This can be overcome by being more creative in the sponsors’ design strategy to reach the endpoints. Sponsors can for instance rely on open source based eClinical Systems (such as CDISC Express or ClinCapture marketed by Clinovo) in order to avoid expensive licensing fees and meet tight budget requirements.

Partner with the FDA

Transparency is an absolute pre-requisite in partnering efficiently with the FDA. It is critical to be detail-oriented and to think upfront to provide and anticipate the information the FDA will need and require. ​Having internal checking prior to the actual FDA submission is critical because “if you have questions or doubt about your data, the FDA will too”, explains Sandra Nino-Siddens, Executive Director of Regulatory Affairs at Geron Corporation.

Sandra Nino-Siddens claims that “sponsors should be straightforward in presenting rationale and steps followed to develop a safe product.” She outlines the importance of building good relationships with the FDA from the beginning and to keep forth-coming interactions with them. Sandra Nino-Siddens states that “the FDA should be seen as a as a long-term partner, and not be seen as the police, nor as a consulting company.”

Olivier Roth, Marketing & Communication Coordinator at Clinovo

If you liked this article, we recommend you to read: What is the prescription drug user fee act in a nutshell

The thousand faces industry

Jul 3, 2012 by Clinovo    1 Comment     Posted under: Events

Interview of Ale Gicqueau, President & CEO at Clinovo

Mar 14, 2012 by Clinovo    No Comments    Posted under: Best-Practices

Hi,

Discover an interview of Ale Gicqueau, President & CEO at Clinovo, and learn more about our services and our vision in the CRO industry. This video was broadcasted by Sy Truong at the last Wuss Conference in San Francisco.

Plug-and-play labs at San Jose BioCenter

Feb 14, 2012 by Clinovo    No Comments    Posted under: Event

I recently went to a networking event at the San Jose BioCenter to learn more about the facility as well as meet people who work there. The BioCenter is a unique facility that allows life science, nanotech, and cleantech companies to plug in to their lab and office space for innovation. By doing so, start-up companies can bypass the costs and time required to set up for research and dig directly in to discovery. I had a good time at the event, meeting people and learning about the incubator in a relaxed, enjoyable environment.

An appealing concept

The BioCenter was founded in 2004 in collaboration with the city of San Jose and the San Jose University Research Center. The facility is 40,000 sq ft and houses about 20 companies and will soon be expanding to almost double its current size. While touring the facility, I saw people from multiple companies going in and out of labs and office spaces, all with the common goal of elevating life through better pharmaceutical, better diagnostics, or bettering the environment.

I met with 2 people from one of the companies in the incubator who are developing a bacterial detection platform for molecular diagnostics. The company in entirety is 7 people, a common theme of the BioCenter. It is an electric environment to see these small companies sharing this large facility. The BioCenter has been at 100% occupancy for the last 5 years. During the crisis in 2008-09, they found a shift from less life science to more cleantech companies moving in, an interesting trend that has stuck with me.

A convenient format to nurture promising research

Some interesting things I learned about the BioCenter and its occupants are that the success rate coming from the incubator is not only high, but often very profitable. Companies have emerged from the space, garnering deals worth 50, 80, even 130 million dollars. A benefit to the companies who do not make it out of the facility is that with this plug-and-play format, decisions can be made quicker and at lower costs, allowing funds to be redistributed to more successful ideas.

I believe that such places play a great role in fostering research, it allows researchers, indivually or in small cells, to start a research program without a big investment and it lowers the risk. At the end of the day, more innovations can be brought to the market.

The event was a great opportunity to learn about the BioCenter as well as meet the tenants. The atmosphere was relaxed, they had yummy bites and my favorite beer, and overall was an evening well spent.

Check out the BioCenter at http://www.sjbiocenter.com to see for yourself what I experienced first hand.

Joshua Elvert
joshua.elvert@clinovo.com
(408) 940 3934