Electronic Investigator Site File: The Solution for Disaggregated Industries
An electronic investigator site file (eISF) technology platform helps life sciences organizations efficiently operate in a disaggregated industry.
8 January 2015
Over the past several years, we’ve seen drug developers drop the blockbuster-era dream of fully-integrated pharmaceutical companies in place of an externalized, networked model of R&D.
Almost all of the leading drugmakers have moved to this model to save money on production, make workflow more efficient, speed up processes, and stay competitive. This shift to the externalized model really began with the impending loss of exclusive patent rights on blockbuster drugs and the lack of new drugs to replace lost sales from the patent rights with the hit of the financial crisis. Pharmaceutical companies realized they couldn’t do their entire R&D in house effectively.
Nowadays, most life sciences organizations operate in a disaggregated industry. Pharma companies are scouring the biotech world for new drugs to produce and working with third parties such as sites, contact research organizations (CROs), and technology vendors to get the drugs to market. It’s common sense that to develop drugs in the externalized R&D model, organizations and third parties must share information externally. But due to its disaggregated nature, information sharing between key players has become more complex, difficult to control, and challenging to secure and regulate.
There are technology solutions available to the industry today that make operating in a disaggregated industry a little easier. For example, our Intralinks Studyspace platform removes common hurdles that life sciences organizations encounter when distributing clinical trial documents and collaborating with third parties. Files created by sites must be separated from documents held by the sponsor (which is why pharma-controlled eTMF aren’t used. A separate, site-specific platform is needed. Sites have full control over their files, even when collaborating with sponsors. Intralinks Studyspace never merges versions of the same file that are in both electronic investigator site file (eISF) and eTMF to make sure that at all times the sponsor and site can access the right files they need compliantly.
Disaggregated R&D Model and the Impact on Clinical Trials
The disaggregated R&D model leaks into clinical trials too. Each of the key players — sponsors, sites, CROs, and technology vendors — must share sensitive information with one another regularly and quickly. Electronic systems have helped facilitate this process given the global nature of clinical trials today. Unfortunately, adopting technology can become complicated when sponsors and CROs use electronic trial master files (eTMFs) for paperwork and files, and investigator site files (ISFs) are still in the paper world. Unfortunately, paper-based ISF systems are a regulatory nightmare for sites, with one-third of the general failings found by European Medicines Agency’s (EMA) good clinical practice
inspectors in 2013 relating to essential documents. Only eight percent of sponsor eTMF systems externalize information to investigator sites, according to a 2014 Drug Industry Association (DIA) survey.
Paper-based ISFs make file management more onerous, and regulatory risks of maintaining such documents are increased. “Companies sharing information in emerging markets need even more control,” said Intralinks’ CEO Ron Hovsepian said. Discrepancies between source data and information in CRFs can happen, but technology can help avert some of these risks.
The Need for Electronic Investigator Site File
There is a solution. To access needed information remotely, you can use an electronic ISF platform that has information rights management (IRM) which ensures source documents remain secure and protected. With eISF, documents can be shared with remote monitors, and the investigator can still maintain control.
While beneficial, the interest of eISF has lagged behind adoption of other eClinical tools. There are two major reasons for this says a DIA survey: technical constraints and financial barriers.
Onsite monitoring visits costs the pharma industry nearly $10 billion per year, with 75% of CRAs time spent visiting sites. Additionally, monitoring costs for a large Phase III trial on average accounts for 15 to 30 percent of a study’s total budget. To reduce costs, sponsors and CROs have been enabling risk-based monitoring — which consists of information being reviewed remotely so CRAs spend less time traveling. Unfortunately, in-person visits can’t be cut out completely since without remote access to ISFs, CRAs still need to visit sites. Luckily, there are effective technical solutions available today that present cost-savings benefits that outweighing the initial investment. However, as we mentioned earlier, through the innovative Intralinks Studyspace platform, the typical barriers life sciences organizations face when distributing clinical trial documents are removed.
To learn more about eISF, check out this ebook by Intralinks and FierceMarkets entitled, “Secure File Sharing in a Disaggregated Industry: How Pharma and Trial Sites Can Rethink Communication.” I hope you find it valuable.
Andrew Mitchell is the director of strategy and product marketing for life sciences at Intralinks. Andrew has many years of experience working in and with the Life Sciences industry, delivering innovative software solutions through his time with Covance, Relsys, Medidata and BioPharm Systems (Oracle Gold implementation partner). With a focus on Software as a Service, he has a strong belief in providing solutions that simplify and improve the user experience and the relevant subject matter expertise to ensure delivery of real benefits and enhanced compliance.