A client, with whom we had been doing some analytical and stability testing, approached our clinical research group about supporting an additional cohort of patients in an on-going Phase I trial. Speed was critical, along with the need for good sites with access to several patients with the highest level of compliance focus was imperative.
Our client reached out to us for help. The challenge with this request was to engage in an on-going trial with an existing team to identify up to five sites capable of recruiting at least 40 patients in a short time period. After the project was scoped and our site identification and qualification process completed (including management of all regulatory / IRB filings), we had less than three weeks to recruit and complete this trial.
Given our years of experience in ophthalmic clinical research, our team had ready access to a number of sites with which we have had great success in other trials. Our relationships with those offices gave us high confidence in their ability to meet the challenge despite the tight timeline. Ultimately, we over-recruited the trial in the allotted time and were able to gather data to support our customer’s corporate goals of publishing data in their requested timeline.