Clinical Operations Management
Through our Clinical Operations Management, in charge of Quality Assurance, we guarantee that all clinical trial activities comply with GCP standards, local regulations, ethic requirements and protocol designs. Among its main responsabilities, it is in charge of preparing the site for oudits and inspectors, and of overseeing the submission of documents to the Ethics Committee and to the Regulatory Agencies. It is also responsable for the supervising the training operations.
By means of this program we have successfully gone through FDA Audit and EMEA audits with no actions indicated and through several Quality Assurance Audits from different clients as well.
Our operations staff performance is measured by several Key Performance Indicators (KPI). KPI have demonstrated to be a valuable tool to induce staff behavior in achieving high standard quality results.
SOME KPI ARE THE FOLLOWING:
- Patient visits performed within the Windows range established by protocol.
- Care in dispensing investigational product.
- Protocol violations.
- Site files
- Days elapsed between the date of visit and the date of CRF transcription.
- Number of queries per patient.
- Timing in solving queries.
We are committed to achieve the highest level of patient care and patient safety. All the staff is trained to give a kind, comprehensive and professional care to meet high standards in patient retention. At this moment, we have an average of 88.6% of patient adherente at the end of the first year or end of the trial. This shows an excellent compliance ratio with treatments.
We are commited as well to deliver clean and consisten ton Schedule data, using Electronic CRF.
It is not easy to obtain and interpret quantitative measures of data quality due to the variety of CRFs and monitoring methods in use. However we have found that a good indicador is the data query rate. Basing on the KPI of the data entry staff, we can state that we have an average rateo f 4 queries per patient, which are solved within 4 days. We achieve this level of quality by providing ongoing training to the staff members, by the client´s feedback, and by auditing our own procederes
The performance of the staff impacts on our client´s satisfaction and data delivery. All new staff is given a comprehensive induction. Their needs on individual training are assessed and the required training is provided on an ongoing basis.
- Good Clinical Practices
- Local regulations
- Specific procederes to conduct clinical trials: CRF completion, source data
- completion, CRF query resolutions, drug accountability records and site files.
- Site initiations, atended by each trial staff
- SOP trining (Standard Operating Procedures)
- Therapeutic areas training – dedicated to specific Studies
- IATA training for lab technicals