LOGISTICS: Managing Recruitment Supplies
by Deborah Borfitz

Nov. 17, 2008 | Globalization of clinical trials has intensified the difficulties in managing patient recruitment site kits at a time when most clinical research organizations (CROs) are short of the tools needed to efficiently get the job done.

So says Ryan Rodrigues, director of marketing and technology for ICD Global, a Downingtown, PA-based print and fulfillment house that specializes in clinical trial materials management. Global trials involve not only producing “regionalized” site kits specific to the language and culture of numerous geographies; they also require navigating the materials through multiple customs authorities, answering subsequent calls for replenishment kits that differ site to site, and solid communication linkages between project managers responsible for document review. “It’s a very fluid situation.”

The chores of finding, storing, packing, and distributing site kit materials are consolidated under one roof at ICD Global, says Rodrigues. For clients, that lessens communication needs, delays, and costs while improving the consistency of messages and designs. Bulk shipping is rarely a viable alternative. Sites already pressed for space will either reject the shipment outright or shove the materials under a table, forgetting their whereabouts.

For customers of its project management services, ICD Global provides a complimentary online tool, called TrialVision, to ensure the right materials get to the right sites at the appointed time, says Rodrigues. That’s no small trick, given that kits can have five to 50 different components ranging from brochures and appreciation items to protocol cards and patient diaries.

TrialVision has 800 users globally that include folks at agencies who design files, clinical research associates who manage supplies at sites, project managers concerned with timelines and the ordering habits of sites, and whoever manages procurement – in short, “anyone who touches study materials,” says Rodrigues. “Trial sponsors primarily utilize the system as a collaborative platform to ensure their global teams are all on the same page on all aspects of their patient recruitment materials supply, from file proofing and production management to inventory levels and site delivery tracking.”

The portal includes a dynamic reporting function that precludes the need to track patient recruitment supplies through a stack of Excel spreadsheets, says Rodrigues. Users can electronically send progress notes to one another or have the system automatically notify appropriate people of critical events, such as the readiness of a document proof for ethics committee review or inventory levels that have dropped below a certain threshold.

Traditionally, TrialVision was used mainly to manage paper case report forms (CRFs) which, like the patient recruitment site kits, involve multiple languages as well as variable data and identities, says Rodrigues. For purposes of managing recruitment materials, TrialVision has had fast uptake. One of ICD Global’s current clients is a top-five CRO doing a study involving two other CROs, 27 countries, and 105 project managers, coordinators, and associates.

With its July release, TrialVision acquired “more robust” notification functionality and reporting capabilities necessary to manage larger trials, says Rodrigues. At the end of October, TrialVision gained a new module to expedite approval workflow for multi-country project management teams involved in getting documents reviewed prior to submission to ethics committees.

Collaborator, as the new module is called, time- and date-stamps document approvals by each user, Rodrigues explains. It automatically generates reminders to look at documents and indicates which ones have already been approved and rejected. In ad hoc review sessions via conference calls, this online review tool allows project managers to mark up documents in their Web browser and see one another’s comments in real time as they collectively discuss edits.

ICD Global, established in 1987, serves 127 customers and is one of only a handful of document management companies that specialize in clinical trials, says Rodrigues. It has delivered recruitment materials to more than 17,000 sites in 105 countries in more than 55 languages.
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This story first appeared in eCliniqua,one of Bio-IT World’s free e-newsletters.