DSP Clinical Research (DSP) has identified five errors pharmaceutical, biotech and medical device companies make when selecting a CRO to conduct a clinical study. DSP is a full service CRO that uses innovative approaches to successfully manage Phase I-IV clinical studies. In identifying the five errors, DSP Executive Director of West Coast Operations Brenda Reese, RN, explained, “When a small to mid-size sponsor chooses a CRO, the decision should be based on finding substance vs. style and facts vs. perception.”
1) Going with a company you’ve always used, “just because.”
Pharmaceutical, biotech and medical device companies face new competitive, regulatory and economic challenges. Instead of automatically assigning new studies to the CRO you’ve always used, try a new approach. If you’re looking for a different result and you’re using the same CRO it’s time to try something new. “The best CROs will welcome the challenge of addressing how they can help you conduct a faster, safer, compliant clinical study,” Ms. Reese said.
2) Going with a big name CRO because it is a safe choice.
When it comes to choosing a CRO, size matters. Ms. Reese said, “Small to mid-sized sponsors might think it’s a prudent decision to award their study to a large CRO because of the resources available to them. However, a small sponsor company is unlikely to get a large CRO’s ‘A Team’ because most large CROs assign their top people to their largest clients.”
3) Mistaking therapeutic experience with study management expertise.
Sponsors want CROs with relevant experience in their indications, but therapeutic experience does not guarantee study management expertise and high quality data delivered. Avoid the pitfall of putting therapeutic experience above study management expertise or past success in other clinical studies. A good Study Manager will deliver a successful study with or without the therapeutic experience.
4) Choosing a CRO based on the lowest bid.
We get what we pay for. Going with the lowest bid can lead to numerous changes of scope which can blow up your budget. “Make sure the CRO bids your project thoroughly including all aspects of running a study,” Ms. Reese said. Ask the CRO to anticipate changes to the number of sites and study design and have them provide sample cost estimates in the proposal. Most CROs will just provide an hourly rate. An hourly rate needs to include an estimate of the hours required to complete the task. “Most studies will have changes and knowing some of them upfront will save you money down the road,” Ms. Reese advised. “A good CRO will plan for changes of scope and include the sample costs in the original bid.” DSP has had only four changes of scope since 2004, with money returning to the sponsors in three of the four cases.
5) Getting caught in a bait and switch.
Choose the CRO that will staff the best team for your study. Every CRO is likely to propose its best team for your study, but will you really get them? Months can pass between awarding and beginning a study. Do not base your decision on CVs and study personnel submitted during the bidding phase, because you have no control over whether those submitted will still be employed at the CRO or available for your study when it begins. Ask for the track record of the study manager assigned to your project. How many studies have they started and completed in the past two years?