According to the studies of Tufts Center for the Study of Drug Development 11% of sites in a given trial typically fail to enroll a single patient, 37% under-enroll, 39% meet their enrollment targets, and 13% exceed their targets.
CRO and pharmaceutical companies need reliable and efficient sites who can meet or exceed the enrollment targets.
CRO and pharmaceutical companies need not only ensure rapid enrollment of patients, but also high-quality of data obtained at the site as well as the quick study start-up and close-out to allow on-time study completion.
At «BioEq», we strive to meet our clients’ requirements for predictable enrollment and quickest start-up and close-out of study activities.
We introduced the following company rules documented in internal politics and SOPs in our routine work with our clients:
- First feedback about the study and signing of a CDA within 12-24 hours;
- Feasibility completion in the shortest possible time (3 – 5 business days);
- Commercial proposal within 3 business days;
- Mailbox check every 24 hours by all employees;
- Protocol expertise and detailed feasibility by main team members ;
- Preparation of enrollment measures for a potential study before its start;
- Assessment of equipment availability for a potential study;
- Assessment of the personnel availability for a potential study;
- Financial assessment of a potential study;
- Availability of start-up documents: team CVs, LEC documents, certificates, diplomas, institution medical license, laboratory ranges;
- Quick signature of needed clinical trial forms;
- Preparation to all types of monitoring visits;
- Preparation of the unit for the start-up: pre-screening of subjects before the start-up, speedy and high-quality enrollment starting from the first day after the start-up;
- Prepared project-specific source documentation templates;
- Annual equipment check, contracts with main vendors;
- Possibility to provide necessary documentation within 12 hours;
- Fast agreement signature process (not longer than 1-2 weeks);
- LEC review upon request;
- Reporting of all AE and SAEs to Sponsor;
- CRF data entry within 1-3 days;
- Query reply every week.
These and other requirements are implemented into the «BioEq» quality management system and their implementation is supervised by upper management and corrective and preventive actions are implemented where necessary.
Our site is interested in long relationship with our clients and its team makes all possible efforts to help our clients successfully predict timelines of their studies and provide solid high quality clinical trial data.