Info & Opinion
July 21, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
IntraLinks is a document management firm with a focus on financial services and life sciences—regulated industries that move around electronic and cellulose-based forms. The New York City company is betting that some forward-looking research organizations will want to manage documents in the cloud.
Last week, IntraLinks announced tweaks to an existing product that make it, for lack of a better phrase, a clinical trial document management system. The system has a new name: IntraLinks for Study Management, and features targeted to the unique twists and turns of clinical trials.
The software includes new ways to help sponsors and contract research organizations (CRO) work with clinical sites. The system can centralize study-related documents and messages; automate the stages of contracting and budget negotiations; help sites avoid repeatedly reentering the same data and documents; and show sites a customized list of their tasks, document requests and due dates. There are audit trails around all of it, so that if anyone needs to reconstruct what went awry at Site 213, it will be recorded.
"We've been used throughout the clinical trial process," notes Alison Shurell, VP of life sciences product marketing at IntraLinks. The company's new product is intended to address the manifold inefficient aspects of starting a clinical trial, most of which involve documents.
Most of the industry continues to use paper to manage trials. Paper, of course, comes with huge efficiency penalties. The process for starting trials is especially document-intensive, and IntraLinks has geared many features toward making it easier. "This process is extremely painful and paper based," she notes.
The IntraLinks system can also be considered, for lack of a more precise term, a project management (PM) system blended with a clinical trial management system (CTMS). "We are facilitating more than document management," says Shurell. The IntraLinks system will keep track of how much of a given activity has occurred, allowing alerts to be sent as soon as something goes a bit off schedule. If an investigator has not supplied a curriculum vitae or a 1572, the IntraLinks system will prompt the person who needs to be prompted.
Speeding Trial Starts
"That allows you to focus your followup," Shurell explains, noting that when paper-based documents are shipped to an address, sponsors and contract research organizations have very little insight into what else has happened to the package. Says Shurell: "Have they opened the package? Have they not even looked at it? What we're hearing, particularly for those doing things in a paper based manner, they really have zero insight."
She says some sponsors of clinical trials would like to use a lot less paper. "The sponsors, the pharmaceutical companies, are very much interested in eliminating paper from their world. They are all frustrated by the reams of paper, the binders, having to ask for things over and over again. It is definitely a pain they feel." CROs are encountering the same issue, she says.
One obstacle to going paperless: the clinical site. Clinicians and scientists still need to use ink to sign large numbers of documents. So while IntraLinks and many sponsors have adopted the SAFE-Biopharma electronic signature standards, the digital signature techniques are still taking root in the investigator landscape.
Getting set up with SAFE is no big deal for GSK, but an expense and a hassle for smaller organizations that still do signatures the old-fashioned way. The head of SAFE has written this blog post on the IntraLinks web site.
Some sites, Shurell is quick to point out, are pushing for electronic document management systems, and getting the attention of sponsors. "They are getting frustrated with paper and want alternatives," Shurell says.
To accommodate the preference for traditional signatures, IntraLinks has developed its own proprietary tools for dealing with hard copies of documents, including a way to drop incoming faxes from sites into exactly the right folder and file directory for safe keeping and regulatory purposes.
The users of the IntraLinks system only need one username and password to access documents on the IntraLinks system. Indeed, Shurell says that some sponsors first check the company's system when signing up new investigators, as thousands of them are already in the system. d9A2t49mkex
As with any web-based system, Shurell adds, IntraLinks really doesn't involve the corporate IT department. That makes it as appealing for CROs as for sponsors, especially since IntraLinks handles the tech support for the system in 140 languages around the globe. "There is no installation of software," Shurell says. "There is no maintenance burden. There is no support burden."