The main role of Accelsiors Safety unit is the collection, verification and presentation of adverse reaction reports to the Sponsor, ensuring that all information relevant for assessing the balance of benefits and risks of a medicinal product is reported to the competent authorities, as well as to investigators and trial participants fully and promptly.
The Serious Adverse Event (SAE) processing system allows for prompt medical assessment, evaluation for determination of causality and expectedness. The procedure outlines time frames regarding reporting of such events to the appropriate Regulatory Authorities (RAs), Institutional Review Boards/Ethics Committees (IRB/IECs) and sending the Investigators Notifications. Any required follow-up information is obtained, reviewed, and reported in a timely manner.
This is achieved by:
- Dedicated, medically qualified, appropriately trained Accelsiors staff
- Full awareness and compliance to the international guidelines and regulatory requirements for expedite reporting
- Monitoring and verification, and periodic review of safety parameters in close collaboration with Accelsiors Clinical Operation Unit, Sponsor, DSMBs
- Direct communication with and reporting to Sponsor’s pharmacovigilance group
- Planning and control of safety monitoring and reporting operations
- Provision of training to all Accelsiors staff and Investigators
- Continuous review of applicable regulatory requirements and continuous professional updating development in the relevant therapeutic indications.
In general, according to the most stringent regulatory requirements, SAEs suspected to be related to the investigational drug, which are fatal or life-threatening and unexpected, qualify for very rapid reporting. Regulatory agencies are notified (by telephone or in writing) as soon as possible after hearing of the event but no later than the time frames specified by the individual RAs. According to the requirements of International Conference on Harmonization (ICH) guideline E2A, all adverse drug reactions (ADRs) that are both serious and unexpected are subject to expedited reporting.
The exact roles and responsibilities of Accelsiors, Sponsor, investigators and third party (if applicable) in each project will be defined in a study specific safety plan. This plan reflects the contractual obligations and agreements. It defines the applicable regulatory obligations, applicable Sponsor/Accelsiors/third party SOPs and procedures to be followed.
Services provided by Accelsiors are:
- Safety and Medical Management plans (including Pharmacovigilance Plans
- Risk Management Plans (RMP)
- Periodic and Annual Safety Update Reports
- Permanenetpharmacovigilance support (24/7)
- SAE/AE/ADR handling (collection, databaseentry and evaluation)
- EudraVigilance registration
- Expedited reporting, including reporting toEudraVigilance
- Assessment and review of patients study eligibility and protocol deviations
- In co-operation with Biometrics medically qualified staff of Accelsiors Safety participates in randomization procedures
- Review and analysis of safety listings and tables
- Pharmacovigilance audits
- Safety signal detection and analysis
- Provision of MedWatch form for all SAEs reports
- Provision of support data for analysis of similar events for IND safety letters
- DSMB member selection
- Assistance in DSMB charter development
- DSMB meeting support and coordination
