Clinical research gets a boost

invivodata’s regulatory expertise enhances INC Research’s global service offering

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PITTSBURGH, Pa.—INC Research Inc., a therapeutically focused contract research organization (CRO), has partnered with invivodata inc., a pioneer in electronic patient reported outcomes (PRO). The partnership evolved from the successful execution of multiple international clinical trials in which INC Research and invivodata clinical service teams have delivered invivodata ePRO solutions and services to global biopharmaceutical customers.

In 2002, invivodata co-sponsored research with the Department of Psychiatry and Behavioral Science at Stony Brook University in New York to determine the validity of paper diary-based patient records. The results were published in the British Medical Journal (May 18, 2002) and found that the mean percent compliance using a 30-minute window for recording data was only 11 percent for paper diaries, while compliance that was self-reported by patients was 90 percent. (The diary binders were unobtrusively fitted with photosensors that detected light when the binder was opened and closed.) Actual compliance among a like number of patients using an invivodata electronic diary was 94 percent.

"We began working with the FDA at that time," says Doug Engfer, invivodata president and CEO, "to help shape PRO guidance and provide expertise to clinical researchers making key decisions about their PRO strategies for global clinical development programs."

The company's approach, he notes, is based on the critical need to bring together the scientific means for measuring mental processes in order to collect reliable data within a controlled regulatory environment. The process combines behavioral science, information technology and clinical research expertise to capture high-quality clinical trial data directly from patients. Among the therapeutic categories where invivodata is most frequently involved are pain, sleep, respiratory, post surgery, gastrointestinal and genitourinary.

invivodata calls its approach "collaborative study management," and Engfer stresses the importance of "getting together early to delineate roles and eliminate redundancies for better efficiency and effectiveness." From INC's perspective, such an approach made a good fit.

"We have a very structured approach to delivering a trial," says Alistair Macdonald, INC Research's executive vice president of strategic development. "We call it The Trusted Process, and it begins with quick-start camps where the team focuses on the project for week—no Blackberries or other distractions. At the end of the week, we have a deliverable that is critiqued by the CEO, COO, business development (team) and others. This process helps us design and implement programs correctly, backed up by six-sigma technology.

"We chose to partner with invivodata based on the integration of scientific and regulatory principles into their ePRO solution—elements critical in ensuring high patient compliance and reliable data," MacDonald adds. "By leveraging our relationship with invivodata, we can continue to guide our customers through any regulatory changes that may affect their research decisions, especially in light of the recent publication of the FDA's final PRO Guidance."

"Having collaborated on multiple international clinical trials to date, invivodata and INC Research have developed synergies between our teams that drive real-world efficiencies in clinical research and better equip our customers to manage their clinical development processes," adds Engfer. As a postscript, he notes that invivodata's consulting division works with clinical research teams to help them navigate the science and regulatory world and ensure they sponsor "ready, aim, fire" procedures.

INC Research creates management program for strategic clinical delivery alliances with pharma and biotechnology customers

RALEIGH, N.C.—INC Research Inc. also announced in late February its creation of a program to create strategic clinical delivery alliances with pharmaceutical and biotechnology customers. The alliance structures, which will be based on joint strategic objectives rather than service-level agreements, will include complete management of a compound or therapeutic area; management of a specific function or set of critical processes; sharing in the risk and reward of a compound's performance; or acting as the sole source development partner for a customer.

"Drug developers are starting to realize that the traditional role of a preferred CRO provider is not producing the financial, efficiency and quality benefits they had hoped for," says Alistair Macdonald, executive vice president of strategic development at INC Research. "We want to take these relationships to the next level by developing commercial level solutions supported by our excellence in clinical trial execution."


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