Clinical trial programs are always challenging and require sufficient infrastructure, knowledge, a dedicated and experienced team and advanced clinical trial technologies to perform the clinical study as per protocol and regulatory compliance. Timeline is the key factor in any study where you will not only meet your study timeline but the financial outcome as well when you launch the product on time. There are many instances where sponsor feel left out when their studies struggle to meet the timeline and compliance. If you feel, you are not in hand of the right CRO partner then we, Abiogenesis, help you to rescue your studies.
If you feel, you are not in hand of the right CRO partner then we, Abiogenesis, help you to rescue your studies. Our study team can plan the strategies and execution methodologies to pull out your studies from bad shape. Get involved to have a smooth transition from your existing CRO to Abiogenesis and Analyze the gap where the study went wrong and correct them to bring it back to normal flow. Support sponsor, vendors, sites and all other involved people to pull in the mainstream clinical study support system.
You can see below some case studies where we have rescued the studies in recent time. Let us know how we can contribute in your clinical development program.
Case Study 1: One of the ongoing studies for FDC where the Sponsor was facing challenges for recruitment. When the sponsor approached us with their study, we found that there was no recruitment in the study from the past 3 months. Our medical and operation team reviewed the protocol, did the feasibility analysis and found out the major challenges for enrolment in the study. We took the project and arrived at a strategic plan for the enrolment of remaining patients in next five months. With aggressive follow-up with the sites, complete support from the operations team and medical monitoring review of each screened patient, we achieved our recruitment target before that projected date.
Case Study 2: During the time of COVID-19, a sponsor approached us for a diabetic study with challenges. A lot of patients were not coming to the sites (hospitals) due to various reasons like transportation problems, the fear of getting infected, family objections and many more. We suggested sponsor that we would support you for the study along with the existing CRO to complete your follow-up and recruitment on time. we discussed this scenario with the sites, principal investigator and the study team to organize the study nurse and study coordinator, and home visits for patient follow-ups. By doing so, we were able to save almost 60% of the study population who were lost to follow up.