Due to the increasingly complex global and local regulatory requirements placed upon the industry, more and more biotechnology, pharmaceutical, and device firms are turning to Clinipace Worldwide and our experts to manage their products' safety profile and reporting responsibilities. Whether you are in need of pre- or post-approval surveillance you can rely on our team to help you to meet your regulatory obligations.
Our dedicated, medically qualified and appropriately trained expert team provides a tailored, yet flexible, pharmacovigilance & safety solution that comply with international and local regulatory requirements.
With over 50 years of combined experience in managing adverse events and the submission of expedited and periodic reports across the product lifecycle our safety team manages all the responsibilities arising from complex constellations of multi-center, multi-national studies, in which the diversified requirements of international pharmacovigilance regulations have always been met with efficiency and high quality standards.
- Development of a trial specific Safety Management Plan
- Preparation and update of Risk Management Plans
- Serious adverse event (SAE) management including collection, documentation, querying and follow-up
- SAE processing within required timeframes
- Medical review and assessment of SAEs
- Medical Dictionary for Regulatory Activities (MedDRA) coding
- Data Safety Monitoring Board (DSMB) – member selection, meeting support and coordination
- Data reconciliation of safety and clinical trials databases
- Writing of narratives for clinical study reports
- SAE training for investigators and monitors
- Standard Operating Procedure (SOP) Development
Medical monitoring by a licensed physician is an essential function to ensure the safety of trial subjects and the clinical integrity of trial results. Our medical monitors have substantial experience in all phases of clinical trials from protocol development to SAE reporting to regulatory submissions. You can be assured that your study will be conducted according to protocol, that your study subjects will be carefully monitored and that you will have immediate visibility into any potential issues or concerns.
As part of our standard operating procedures (SOPs), the study team will create a Safety Plan (SP). The SP will include the parties responsible for managing the safety process, including monitoring by a licensed physician, as well as specific reference to SOPs and local guidelines to ensure proper management and reporting of any adverse events.
Adverse Event Tracking
All Serious Adverse Events (SAEs) will be entered by the investigative sites into the TEMPO eClinical Platform, whereupon an automatic notification of the SAE will be generated and sent to the designated safety team via email. The safety team typically includes the assigned Medical Monitors, Safety Associates, Project Manager and Sponsor personnel as requested. Upon notification of the SAE, the Clinipace Safety Associate reviews the SAE report to determine if the report is complete and what additional information is required. Depending upon the site location, the local Medical Monitor or Safety Associate may contact the site to discuss the event or obtain additional information in local language.
Adverse Event Reporting
Depending upon their findings, the assigned Safety Associate and Medical Monitor will then make the determination if an event is reportable, (e.g., unexpected and related to study treatment), and creates the narrative for each event. International requirements for reporting timelines for each country are reviewed and implemented by the local Safety Associate and Medical Monitor.
Comprehensive Reporting Services
Pre-Approval Clinical Trial Safety
- Provision of regulatory report forms (CIOMS I and Medwatch 3500a)
- Regulatory reporting to authorities, institutional review board, ethics committees, and investigators
- Country specific regulatory reporting
- Electronic safety reporting (ICH E2B)
- Preparation and submission of annual safety reports (ASRs), IND Annual reports, development safety update reports (DSURs) and other aggregate line listing safety reports
- Management of Adverse Drug Reaction (ADR) information from the post-marketing area including documentation, case processing, medical assessment, query process and follow-up
- Regulatory reporting of serious ADRs to national and European Medicines Agency
- Serve as the EU Qualified Person for Pharmacovigilance (EU QPPV)
- Developing the Pharmacovigilance System
- Generation of Periodic Adverse Drug Experiences Reports (PADER), Periodic Safety Update Reports (PSUR), & New Drug Application (NDA) periodic reports
- Signal detection and evaluation with respect to update the Company Core Safety Information (CCSI)
- Risk evaluation and mitigation strategies (REMS)
- Serve as Responsible Person for EudraVigilance (RP-EV)
- Registering of company headquarter, affiliates, third party providers and users
- Medicinal product dictionary entries (XEVMPD)
- Testing procedures
- EVWEB: Reporting of suspected unexpected serious adverse reactions (SUSARs) and individual case safety reports (ICSR) with the Webtrader function
Aggregate PADER/PSUR reporting, including:
- Tracking of reporting periods and submission dates
- Generation of tables and listings from safety database
- Analyze line listings and prepare relevant tables
- Analyze previous aggregate reports for the product
- Compose case summaries and analysis
- Draft report for client review and approval
- Medical review of each report