Adverse Event Management in Clinical Trials, Observational Studies & Post-Marketing (Spontaneous Reporting)
Mapi has extensive experience of processing Individual Case Safety Reports (ICSRs) throughout the entire lifecycle of a product, from first in man studies through to post-authorisation activities. Mapi provides flexible options allowing clients to select a process that best aligns with their planned or ongoing pharmacovigilance activities.
Complete ICSR Processing
Mapi can provide a complete service for processing of ICSRs within their in-house validated safety database, or directly into a client’s safety database. The department’s experience includes ARISg, ARGUS, Empirica Trace, AERS and clients’ own proprietary databases. Mapi has experience of managing ICSRs from healthcare professionals, consumers, medical information enquiries, client employees, client partners, sales representatives, published medical and scientific literature, regulatory agencies, clinical trials, observational studies, investigator sponsored studies, compassionate use programmes and many other sources. Processing includes:
- Data collection;
- Data-entry, narrative generation, quality control, MedWatch/CIOMS report generation;
- Medical review, including MedDRA coding review, expectedness assessments, seriousness assessments and preparation of company comments / analysis of similar events by pharmacovigilance trained Safety Physicians;
- Expedited reporting to global regulatory agencies, including E2B submissions;
- Requesting additional information to validate ICSRs or to obtain additional clinical details.
Pass-through ICSR Processing
Mapi can provide a selection of ICSR processing workflow steps to supplement the client’s existing ICSR process, including:
- Receipt and confirmation of source ICSR data and transfer to client’s pharmacovigilance contact points, e.g. from investigator sites;
- Data-entry of select ICSRs into a client’s safety database;
- Medical review of ICSRs;
- Expedited submissions to regulatory agencies in certain jurisdictions;
Adverse Events in Interventional Clinical Trials
Mapi’s pharmacovigilance group is experienced in processing adverse events taking place in interventional studies (phase I to IV clinical trials). Considerations additional to those described above include:
- Generation of data clarification requests;
- Unblinding of SUSARs prior to expedited submission to regulatory agencies and central ethics committees, if required by jurisdiction-specific legislation;
- Preparation of Analysis of Similar Events, if required by jurisdiction-specific legislation;
- Distribution of SUSARs to ethics committees and investigator sites;
- Reconciliation with study databases.
Adverse Events in Non-Interventional Studies
Mapi is very familiar with the challenges of collecting and processing adverse events from observational/non-interventional studies. Mapi has expertise of pharmacovigilance regulations and scientific guidelines that apply to different study designs (including primary data collection or secondary use of existing data) and their appropriate reporting requirements. Mapi is expert in translating such requirements into study-specific Safety Management Plans. Often sites are overwhelmed and experience high turnover rates of site coordinators. Ongoing education at the site level is necessary for successful querying for additional safety information which is pertinent to an event. Safety queries are targeted to limit extraneous information and focus on the reported event. Our goal is to limit the burden of safety follow-up at the site level by clear concise queries. Our pharmacovigilance staff will meet with study coordinators and discuss open queries and techniques which bring cases to completion.
Adverse Events in the Post-Marketing Setting (Spontaneous Reporting)
Mapi has experience of managing ICSRs from healthcare professionals, consumers, medical information enquiries, client employees, client commercial partners, sales representatives, medical liaisons, published medical and scientific literature, regulatory agencies and many other post-marketing sources.
Obtaining quality data in the post-marketing setting is challenging, requiring a commitment to follow-up with reporters to obtain high value clinical information. Mapi has experience in managing targeted follow-up of Adverse Events of Special Interest, particularly those associated with Risk Management Plans.
There is also opportunity to collaborate with Mapi’s Direct to Patient services for tailored patient interactions.