The contract research organization (CRO) launched the new co-monitoring service which provides back-up certified clinical research associates able to begin work full- or part-time within two weeks of a signed contract.
Under the pricing and model structure monitors are paid by the visit rather an hourly rate or fixed salary, explained Darlene Panzitta, president and founder of DSP Clinical Research, who told us this allows DSP to “step in and provide an efficient and affordable short-term monitoring solution when needed.”
“It also affords DSP to keep a larger monitor pool, taking advantage of the fluctuations of individual monitor’s schedules so that they can supplement short periods of 'white space' in their schedules without having to commit to a full-time project,” she added.
The company has previously provided companies, including a large CRO and pharmaceutical client, with supplemental monitors to help initiate a study or prepare for an upcoming audit, among other work.
“Onsite monitoring is a key component to the success of a study. To control the associated costs, our industry has become very focused on finding ways to limit the time and travel associated with onsite monitoring visits,” said Panzitta.
“We have developed technology and adopted risk-based monitoring to this end, however, it seems we've lost sight of the fact that onsite monitoring includes a lot more than just source data verification.”
Panzitta called managing monitoring staff “a constant balancing act,” though she said it is easier to ensure training is in line with practices, policies, and procedures with full-time employees. Yet the number of studies is always in flux, she said, meaning sometimes there is less work, and other times it's “all hands on deck.”
“As a CRO, we've developed a team of monitors with flexible schedules, experience with the top five EDC systems, and the ability to perform tasks like drug accountability and regulatory document review consistently and efficiently,” Panzitta said. “By offering their expertise to other companies in a pinch, we can utilize the times that we have excess capacity for the betterment of all involved.”
