· 2 min read · By Clinical Trials
How Sponsors Should Choose a CRO for Early-Phase Studies
A practical checklist for sponsors selecting a clinical research organisation in India: accreditation, volunteer database depth, safety infrastructure, timelines and the questions to ask before signing.
Start with accreditation and compliance
Before anything else, confirm that the CRO holds valid accreditation from recognised bodies and that its ethics committee is registered. Ask for inspection history, not just certificates. A CRO that has passed recent regulatory inspections with minor findings is usually a safer partner than one that cannot show any inspection record at all.
Look at the volunteer database, not the brochure
Early-phase studies live and die by recruitment speed. Ask how many pre-screened volunteers the CRO can reach, how their eligibility records are verified, and how they handle the 90-day washout rule. A CRO using a verified volunteer pass system can confirm a candidate's dosing history in minutes, while others spend weeks on phone calls and paper checks.
Ask for real numbers: average time from study award to first volunteer screened, and screen failure rates on their last three studies.
Safety infrastructure matters more than price
Phase I units need round-the-clock medical cover, emergency resuscitation equipment, and a written escalation protocol. Visit the site if you can. Check that the pharmacy stores investigational products with temperature logging, and that adverse event reporting timelines are written into their standard operating procedures.
Compare timelines and communication
A good CRO gives you a week-by-week recruitment plan with milestones, not a single optimistic date. Ask who your day-to-day contact will be and how often you will receive enrolment reports. Weekly dashboards beat monthly summaries when a study is falling behind.
The questions that reveal the truth
Ask what went wrong on their last study and what they changed afterwards. Ask how many studies they run in parallel and whether your study will compete for the same volunteers. Ask how they bill for screen failures and dropped volunteers.
Sponsors who ask hard questions early sign fewer amendment letters later. Choose the CRO that answers with data, not the one that answers with promises.