What is the Due Diligence Visit (DDV) and What is its purpose?
Due Diligence Visits (DDV) are carried out as part of the Site Alliance program between PAREXEL International and member - institutions. It helps PAREXEL Alliance sites to understand and reduce quality risk in the general management of clinical trials, which in turn can improve their performance. The program was initiated in 2015 for its impact on PAREXEL deliverables in contracted projects as well as to provide assurance to our clients of the Alliance Members Institutions highest quality level to prioritize their selection to studies. The DDVs are conducted in the spirit of the alliance relationship with an aim to provide constructive feedback on areas for improvement both within the institution and within PAREXEL.
What is reviewed at the Due Diligence Visit?
DDVs include, but are not limited to, a review of:
- quality system and standards,
- facilities and equipment,
- staff professional qualifications and resourcing processes for clinical trials,
- oversight mechanisms in place for conducting & managing clinical trials, including issue management and compliance with applicable regulations (local and international),
- standard operating procedures (SOPs),
- PAREXEL/site contractual requirements,
- ICH GCP and GMP standards
A dedicated Site Alliance Manager (SAM) assists the PAREXEL Quality Manager in the DDV.
How does the DDV help improve both system and operational processes?
Clinical research is constantly evolving. The ever-changing regulations, guidance documents, increased protocol complexity, new tools and technologies for data capture, and evolution of researchers themselves require continuous review of quality assurance programs, as well as solicitation of feedback from related compliance programs. A more risk-based approach to monitoring is necessary. PAREXEL utilizes DDVs to help identify gaps early on, better understand trends and areas for improvement, and observe the site in action to provide suggestions to improve processes. Conducting DDVs also helps to facilitate the collaboration between PAREXEL, sponsors and Alliance Site members, while helping sites to be audit and inspection ready at any time.
So, the benefits of DDV can be well worth the extra effort required. The list of observations generated from the particular DDVs are shared by dedicated Site Alliance Manager (SAM) with the Single Point of Contact (SPOC) at Alliance Member institutions. Together, they discuss how the information can be used to improve procedures and processes relating to the conduct of clinical trials.
What can the Site SPOC do to help optimize the outcome for the DDV?
Alliance members who have been through Due Diligence Visits have expressed that they appreciated the feedback and opportunity to improve their processes. It is important to realize the right expectations before Due Diligence visits and conduct it in collaborative manner. Therefore, before DDV it needs to be confirmed:
- Access to hospital facilities - Ensure appropriate pre-approvals/authorizations obtained from hospital administration prior to Due Diligence Visit to allow PAREXEL Quality Managers visit e.g. imaging rooms, laboratory facilities, main hospital archival areas
- Responsibility to prepare the adequate Corrective Action and Preventive Action (CAPA) responses and adherence to timelines
So far, there have not been any critical findings observed in any of Alliance Member institution which participated in a Due Diligence Visit. The most common observations are presented below in Chart A. In addition, in Table 1 below you will find detailed descriptions of the findings which may help you avoid experiencing any of these situations.