Much advancement in technologies such as Open
standards, Cloud computing, Mobile
access and tablets (computing devices) have been utilized in the life science
sector especially in Clinical Research Industries. However, despite the cost
and compliance advantages offered by many of these advancements, clinical
research firms are still slow in adopting them. Research conducted across
various analysts shows this dynamics is about to change.
Technology
Shift:
In the recent years, many CRO’s and pharmaceutical companies
are now meeting compliance regulations with less complexity and cost when
compared to the past. There is also a technology shift that the peer organizations
are starting to take advantage of. A very good examples is that Sanofi Aventis,
when the company first adopted an open platform, it estimated the changes being
made would remove over $9 million per year in costs associated with time wasted
in managing documents.
Open
Standards:
Various
surveys were conducted to determine the impact of these technology shifts on
clinical research. One of the main impacts was on Microsoft’s
SharePoint and the other on adoption of electronic trial master files (eTMF).
This shows us a very clear and increasing shift to open software platforms. Looking back, this trend started in 1990’s when clinical
research industries started managing documents electronically ( REF: 21 CFR
Part 11). This is a stark difference from the newer solutions hitting the
market which now reside on open, non-proprietary platforms.
In its SharePoint for Life Sciences Survey, NextDocs asked if firms were
scaling back on proprietary systems in favor of more open-standard platforms
like Microsoft’s SharePoint. In 2012 only 22% of respondents said yes. By 2013
that number had grown to 35%. The survey also asked what system most firms were
replacing when they made the switch to SharePoint. Almost half of those surveyed
were replacing EMC’s Documentum, followed by Oracle WebCenter, OpenText
Livelink, CSC FirstDoc, Master Control, and IBM Content Manager.
EMC’s Documentum is a multipurpose document management solution not
specifically built for the life sciences industry. In Earlier days, pharma
companies had large IT budgets and IT staffs, and were growing fast. Today that
growth rate has been cut in half, and many applications no longer meet the
needs of customers looking for mobile access and cloud computing capabilities.
Those same firms are now finding commercial, off-the-shelf collaboration
platforms from trusted vendors like Microsoft which can run applications
purpose-built to manage clinical trials.
SharePoint And eTMFs Reduce Cost
A second trend is platforms like SharePoint managing regulated
content, a space that hasn’t traditionally used SharePoint. Most life science
companies have SharePoint running somewhere in the organization. Historically,
companies have been using SharePoint to manage their intranets and create
project team sites. While these applications were important for collaboration,
they were not regulated.
It is been observed that the use of SharePoint in clinical trial document management,
FDA submission documents, clinical trial activities, change controls, and
complaint management has tripled when compared to earlier. These are areas
where firms are required to show they have an audited process, and SharePoint can
be used to prove compliance.
The third trend is the use of electronic trial master files (eTMFs) to manage
the large volume of clinical trial documents. Over half of the companies
participating in the survey indicated they were using some type of eTMF for all
or part of their studies, or were currently evaluating it. Only one-third of
respondents had no plans to use it, or weren’t sure.
This below example is the best one to show how important is eTMF and its
reduced cost.
In 2007 Sanofi looked at the paper generated from one of their trials. One
trial can easily generate over 25,000 documents. When you consider that a
company like Sanofi will run anywhere from 150 to 200 clinical trials per year,
moving to electronic master files will result in a tremendous amount of savings
both in cost and in human labor required to manage all of that paper.
Advantages of eTMF:
- Increased productivity.
- Improved audit results.
- Reduced time to prepare study milestones and events.
Mobile Devices & Cloud Computing Simplify Access
The fourth and fifth trends involved the increased use of mobile
devices and cloud computing in clinical trials. While eTMFs will substantially
reduce the amount of paper in clinical organizations, the content of those
documents still has to be reviewed by investigators around the world. More and
more, those investigators want to access content using mobile devices like
iPhones and tablets. This trend creates additional challenges for firms.
Access to eTMFs has to be regulated, both in terms of who can access them and
how they do so. A clinical study might take place at 50 different sites, and
each site will have several investigators. These investigators, typically
physicians, don’t want to have to log into a content management system. They
just want to quickly find the document they need, sign it, and submit it. They
realize the easiest and quickest way for them to do this is via a mobile
device. The use of tablets in clinical trials is not common right now, but the industry
believes it will soon be taking off.
Finally, the increased use of cloud platforms for regulation and
compliance. For years companies were not sure if the cloud could be used for
compliance, or if the FDA would accept its use. Now it is believed that more
clinical firms are finally getting past the fear stage and adopting the
technology. One of the big drivers of that change is the need and desire of
clinical firms to collaborate with individuals outside the company, including
investigators, CROs, universities, and pharmaceutical and medical device
companies.
What is holding companies back is not the cost of these new technologies, but
the fear of going to something new. But we are to the point where companies can
see the advantages of going to an open, collaborative platform. Up until now,
dealing with technology issues has been like playing Whack-A-Mole. Each time
you knock down one issue, another one pops up. CRO’s are aware of the
limitations of their systems, which is allowing market analysts to help them
understand how open solutions fit their specific needs, and help them to
finally get past that inherent fear of change.
