According to Cutting Edge Information Research, Complex Contract Negotiations Delaying Clinical Trials

RESEARCH TRIANGLE PARK, NC--(Marketwire - October 8, 2008) - Clinical Trials are facing significant delays due to hang-ups in contract negotiations, according to a new report by Cutting Edge Information. According to "Streamlining Clinical Trials," contract negotiations were cited by almost every company surveyed as a source of significant delay, and this challenge ranked second only to patient enrollment as an opportunity to speed up the clinical trial process.

Private investigators and universities have different contract procedures, but in both cases the number of people who are involved in the contracting process creates bottlenecks and confusion. Some investigators are less flexible about the legal language, which leads many companies to have backup language ready to speed up the process. Finally, Institutional Review Boards are often very particular about the company-specific nondisclosure agreements.

According the report, some companies are entering into master agreements with investigators and CROs to reduce the amount of haggling before each trial. While master agreements require a significant time investment upfront, in the end these agreements can save time and money.

"With complex contract negotiations taking place, pharmaceutical companies are finding it more difficult to recoup their investments," says David Richardson, research team leader at Cutting Edge Information. "Bottlenecks in the contracting process extend development time, which reduces the number of years a brand is on the market without generic competition."

"Streamlining Clinical Trials" (www.clinicaltrialbenchmarking.com) covers resource allocation, performance measurement, continuous process improvement, patient and investigator recruitment and adaptive trial designs. Data includes clinical development budgets, clinical operations team structures, performance measurement and management, clinical operations hurdles and process improvement tools and tactics. The report focuses on three aspects:

Patient Recruitment: Patient recruitment continues to dominate clinical timelines and budgets. The report devotes an entire chapter to this challenge, providing the latest trends and tools in recruitment.

Budgeting and Performance Assessments: Clinical project managers must set clear performance expectations and measure and manage trials. The report provides clinical spending benchmarks to assist in trial budgeting and planning.

Clinical Operations Structure and Work Flow: Clinical trial management team members must know their roles and responsibilities, and communication with vendors and investigators must be seamless. The report outlines major obstacles clinical teams face and presents real-company, proven solutions.

Contact Information: CONTACT INFORMATION: David Richardson 919-433-0216