Vendor Transition in Pharmacovigilance: Points to consider
Vendor activities are always of prime importance in pharmacovigilance. They are scrutinized very thoroughly by regulatory agencies. Guidelines are very clear about compliance expectations about vendor activities, but few things are mentioned about how to manage vendor transitions. Why vendor transition in pharmacovigilance is different than other areas of clinical research? Main reason is nature of activities and requirement of regulatory compliance. In terms of project management, project has a start date and an end date. Pharmacovigilance is an operation, which is an ongoing process and Gap of even one day can result in non-compliance and backlog. Detailed planning is required for all the transition activities.
What are the reasons for vendor transition?
1. Poor Quality of Work on the part of vendor
2. Non-compliance to regulatory requirements
3. Cost
4. Service provider stops providing services
5. Merger of service provider in another company
In either scenario, when Sponsor is changing the service provider or service provider is changing business strategy, transition should be planned very thoroughly and all the activities should be shifted after all the due considerations. Herein, I have tried to simplify the process for transition of all the aspects of pharmacovigilance activities:
- Due Diligence
- Data Acquisition and Migration
- Functioning of new system
Due Diligence
Inquire about standard operating procedures and workflows. Experience of technical team is the key. Vision and mission of company the company is also important to ascertain the stability. Access the impact of change in systems and standard operating procedures. Perform gap analysis. Check for validation certifications and operational patency check of new system. In case your service provider is being merged with other entity, check all the legal documents regarding merger and its impact. Take the interviews of existing employees and take their feedback regarding new organization in which they are being transferred, whether they have been treated fair or not in all this process. From legal perspective, it is going to be your new vendor. All the PV agreements, Master Service Agreements, Plans and PSMF needs to be updated. Intimate all your partners and distributors along with regulators regarding change in service provider.
Data Acquisition and Migration:
Make a list of data points needs to be transitioned. Decide a cut-off date and a new start date. Jot down the plan how activities between that period will be handled. Prepare an elaborated data migration plan. Map E2B and non-E2B fields of database and check with dummy data. Ask for old audit reports for all the activities. Ask for transfer plan of Non-database documents and whether new service provider is ready for archival or not.
Functioning of new system:
Always take the mock run of current system of new service provider before taking any decision. Access whether system is capable enough for smooth transition or not. During set-up, deploy extra quality check and vigilance for clearance of back-log and regulatory compliance. Perform due diligence audit in first month and periodically during first year.
Remember, for pharmacovigilance, your service provider is not only vendor, but partner – more like a spouse….choose wisely, so you don’t end up to follow this advise