Clinical Trials Adverse Event Processing
Clinical trials play a crucial part in any drug development life cycle where it is key to gain information on a product’s safety profile.
The PharmaLex international team of clinical safety experts, with large expierence in the management of clinical safety activities, effectively supports sponsors with Pharmacovigilance activities during clinical trial development programmes.
PharmaLex designs and implements clinical trial safety procedures allowing sponsors to properly identify, manage and monitor the safety information of products involved in clinical trials. Also, PharmaLex ensures compliance with global and local regulatory requirements regarding clinical safety data processing and submissions.
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Beyond The Pill
During your product development stages, the clinical safety team offers a full range of Clinical Safety Activities in compliance with Good Clinical Practices and in line with Global and local regulations (Directive 2001/20/EC or Regulation No 536/2014 in Europe; 21 CFR 312.32 / 21 CFR 320.31 / 21 CFR 312.33 in the US; and other applicable local regulations).
Thanks to our international footprint and to our certified network of partners (complementing our services in areas we do not cover ourselves), PharmaLex is able to provide Pharmacovigilance services for Clinical Trials conducted world-wide.
- Effective communication with all parties involved
- Team management – proper level of expertise
- Oversight – ensure success
- Management of third parties
PV Clinical Trials system design
- Safety Management Plan (SMP)
- Study Forms
- Clinical Safety SOPs & other relevant procedural documents
- SAE management
- Safety Writing (DSURs, SUSAR-LLs, other)
- Safety submissions to Regulatory Authorities, Central Ethic Committees and/or Central Institutional Review Boards and to investigators.
We offer global solutions covering the entire product lifecycle
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
PV project management & oversight
PharmaLex maintains oversight of PV activities performed for a specific project through periodic meetings held between the appointed PharmaLex Clinical Safety Lead and sponsor, CROs or other parties involved in the project.
PharmaLex project management comprises project set up and staffing, training set-up, project coordination, internal and external communication, budget and invoicing, successful operations as well as adherence to timelines. Other tasks include designing/maintaining KPI’s strategy with regards to PV processes performed by PharmaLex, provide support during audits and/or inspections and consultancy services.
PharmaLex’ clinical safety solution is tailored for each client. Main study setup activities include:
- Support during safety database configuration.
- Investigation of clinical safety requirements from Regulatory Authorities, from Central Ethic Committees and/or Central Institutional Review Boards and from investigators.
- Delegation process to ensure readiness for safety submissions (e-platforms, power of attorneys)
- Design of clinical safety Procedural documents, including the preparation Safety Management Plan (SMP) and of specific study forms (aligned with protocol/IB) used by investigators to share SAEs information.
- Team design, training, support with configuration of relevant sharing platforms/IT solutions.
Case processing includes reception of SAEs/Pregnancies/AESIs (as applicable), review of minimum criteria/missing information/plausibility/discrepancies, expectedness assessment, preparation and distribution of follow-up requests, data entry/QC in database (including coding activities & narrative writing), preparation of standard reporting forms (CIOMS I, MedWatch), unblinding, and other activities (such as performance analysis of similar events in the US). Other related activities (as required) are performed as providing listings for reconciliations/other purposes or maintaining case trackers.
PharmaLex prepares DSURs, IND Annual Safety reports, Line Listings or other aggregate reports.
A Kick-Off meeting with all involved stakeholders is conducted and led by PharmaLex. The goal of this meeting is to clarify process and timelines and to require relevant information. Once the information has been collected, PharmaLex prepares the DSUR according to ICH E2F guidelines and/or other relevant local legislation/guidance in place. An internal review by a different safety writer (and safety physician, if needed) is performed.
PharmaLex performs safety submissions (SUSARs, DSURs, SUSAR-LLs) to applicable Regulatory Authorities, Central Ethic Committees / Central Institutional Review Boards and to investigators. Other safety submissions may also be performed when (and where) required by the sponsor or by NCAs or CECs/CIRBs or by investigators in specific countries.
PharmaLex performs all submission by complying with local regulatory requirements (that are clearly included in the SMP of the concerned study-ies).
Gap Analysis and Consulting
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Monitoring and Signal Detection
PharmaLex customizes the signal management activities as per client requirements ensuring reliable, high quality, trackable data in compliance with the regulatory guidelines (e.g., GVP Module IX & FDA Good Pharmacovigilance Practice and Pharmacoepidemiologic Assessment). In addition to Signal management services, our team of experts are also experienced and well versed in providing responses to safety questions from the Health authorities by providing strategic advice on the approach to respond to the HA query; evaluating and critically appraising ICSRs, aggregate data, and literature and thereby providing a comprehensive evaluation report considering the strengths and weaknesses of all the data sets and sources reviewed.More Info
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Qualified Person for Pharmacovigilance (QPPV)
If required, PharmaLex can take on the tasks and responsibilities of the EU Qualified Person Responsible for Pharmacovigilance, or provide a deputy in times of absence or illness.More Info
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