Pharmacovigilance
Safety of medicinal products is one of the main responsibilities of sponsors during clinical development. Kinesis Pharma has recognized the fact that many start-up companies appreciate help in organizing the mandatory pharmacovigilance arrangements before starting clinical activities. Therefore Kinesis has recently added pharmacoviglance to the service offerings.
The pharmacovigilance department of Kinesis has a well-trained staff including a Qualified Person for Pharmacovigilance (QP-PV) and a validated and E2B compliant safety database in order to perform the mandatory reporting of (early) clinical trials to authorities, ethical committees and investigators.
Serious Adverse Event Management
Efficient (serious) adverse event management is a significant part of clinical trial execution. The pharmacoviglance department of Kinesis offers all aspects of safety management related to processing of Serious Adverse Events and (Serious) Adverse Drug Reaction reports (SUSARs) for clinical research trials within the EU.
Kinesis’ pharmacovigilance service offerings include:
- 24/7 medical and safety coverage
- Trial-specific SAE report form including clear completion guidelines for the investigator
- Pharmacovigilance training to trial personnel
- SAE/ADR management: Daily receipt & acknowledgement, data-entry, medical review, assessment of relatedness and expeditedness with subsequent assessment of reportability, Quality Control,
- Expedited Reporting: Kinesis sends the reports via Gateway or via EVWEB (Kinesis has certified staff for EVWEB). Reports can be sent to Health Authorities, incl. Eudravigilance, Ethical committees and investigators
- Registration of sponsors with Eudravigilance including the Eudravigilance Medical Product dictionary (EVMPD)
- Literature search
- AE/SAE reconciliation between the clinical database and the safety database at trial closure
Prior to trial start, Kinesis always prepares a trial specific and clear pharmacovigilance management plan between sponsor and Kinesis in order to clearly describe the pharmacoviliance obligations between different parties.
Period Reporting
Kinesis pharmacovigilance department is able to prepare and/or review the following period reports for sponsors:
- Periodic Safety Update Reports (PSURs)
- Annual Safety Reports (ASRs)
- Periodic Adverse Drug Experience Reports
Kinesis pharmacovigilance department has its own templates for these periodic reports but sponsors templates can be used as well if preferred.
QP-PV
According to European legislation, Marketing Authorisation Holders are required to appoint a QP-PV and a deputy QPPV residing in the EEA. Kinesis is able to offer this significant responsibility including the 24/7 availability for sponsors outside the EEA but also for small start-up companies within the EEA.
Prior to taking the responsibility of QP-PV, Kinesis always prepares a pharmacovigilance agreement including a description of the different tasks and responsibilities between sponsor and Kinesis. In this way, it is guaranteed that pharmacoviliance obligations between different parties are described clearly and all parties can fulfill their tasks appropriately.