Drug Safety and Pharmacovigilance Services
Safety of medicinal products is one of the main responsibilities during clinical development and after registration. Kinesis Pharma has recognized the fact that many start-up companies appreciate help in organizing the mandatory pharmacovigilance arrangements before starting clinical activities. In addition Kinesis can support post-marketing periodic reporting.
Kinesis has well-trained staff in pharmacovigilance services including a Qualified Person for Pharmacovigilance (QPPV) and a validated and ICH-E2B compliant safety database in order to perform the mandatory reporting of (early) clinical trials to authorities, ethical committees and investigators.
SAE Management and reporting
Efficient (serious) adverse event management is a significant part of clinical trial execution. The pharmacovigilance services of Kinesis offer all aspects of safety management related to processing of Serious Adverse Events (SAE) and (Serious) Adverse Drug Reaction (ADR) reports (SUSARs) for clinical research trials within the EU.
Kinesis’ pharmacovigilance services 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 EU EudraVigilance Web (EVWEB, Kinesis has certified staff for EVWEB). Reports can be sent to Health Authorities incl. Eudravigilance, Ethical committees and to investigators
Registration of sponsors with Eudravigilance
- AE/SAE reconciliation between the clinical database and the safety database at trial closure
Prior to trial start, Kinesis always prepares a trial specific pharmacovigilance management plan between sponsor and Kinesis in order to clearly describe the pharmacoviliance obligations between different parties.
Periodic Safety Reports
Kinesis is able to prepare the safety reports for sponsors:
Safety Risk Management Plans (RMP)
Periodic Safety Update Reports incl. a benefit –risk section (PSURs/PBRERs/PADERs).
Annual Safety Reports and Drug Safety Update Reports (ASRs/ DSURs)
According to European legislation, Marketing Authorisation Holders (MAH) are required to appoint a QPPV (Qualified Person for Pharmacovigilance) 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 QPPV, Kinesis always prepares a pharmacovigilance service 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 and responsibilitites appropriately.