Applied Clinical Trials
Pharma needs to find a balance in working with Sponsors and CROs in order to streamline the study processes.
The problem with overbearing project managers on the sponsor side of the pharma/contract research organization (CRO) equation is that they dynamite the efficiencies CROs are hired to deliver.
"Micromanagement hurts us in the long run," said Colleen Cox, Senior Manager, Data Management at Infinity Pharmaceuticals, at CBI's Sponsor/CRO Systems & Business Process Integration conference in Raleigh, NC this past November. Pharma doesn't always like ceding control to external groups, but it's necessary, said Cox. Apart from slowing down a project, micromanagement also "damages trust" between partners, she said.
Ian Lauf, Associate Director, Clinical Alliance Management at Eisai, countered that consistent oversight isn't the same as micromanagement, noting regulatory authorities "need to know the sponsor is in charge." However, Lauf agreed sponsors sacrifice key CRO efficiencies—like speed—when they "force their SOPs on their partners," rendering CROs into extensions of internal employee personnel.
Stefan Proniuk, VP of Product Development at Arno Therapeutics, a virtual company focused on early stage development, said Arno doesn't have the resources to micromanage its CRO partners, even if it wanted to; small virtual biotechs live and die by the performance of their partners, and the CRO's ability to hit deadlines for investors. "Venture capitalists want their money back in five years," said Proniuk, adding that for early-stage virtual companies, the process beginning with preclinical chemistry, manufacturing and control, and toxicology studies, and ending with the conclusion of Phase II trials should last 48 months, maximum. For virtual companies, the four most important CRO capabilities, per Proniuk, are: speed, speed, speed, and quality, which can't be compromised.
As pharma and CROs shift toward integrated partnering models that put CROs on more equal footing with drug sponsors, pharma will need to reexamine and focus on its remaining key competencies, and make tough decisions about internal headcount as more functions are outsourced.
Editor's Note: CBI, Applied Clinical Trials, and Pharmaceutical Executive are owned by Advantar Communications.