Connect with Megalek about your upcoming clinical trial
Request a proposal
Connect with Megalek about your upcoming clinical trial
Request a proposal
Connect with Megalek about your upcoming clinical trial
Request a proposal
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Pharmacovigilance
MegaLek, as a Pharmacovigilance Partner, provides end-to-end pharmacovigilance services to precisely compliment client’s needs in either Europe, CIS, and the Russian Federation or the USA .
CLINICAL DEVELOPMENT SOLUTIONS OVERVIEW
Pharmacovigilance
MegaLek, as a Pharmacovigilance Partner, provides end-to-end pharmacovigilance services to precisely compliment client’s needs in either Europe, CIS, and the Russian Federation or the USA .
Fully or partially outsourcing the pharmacovigilance services:
- At MegaLek, pharmacovigilance is stipulated by the Standard Operational Procedures that are supported by Quality Management System;
- We are familiar with legislation of Europe, CIS, Russian Federation and the USA and experienced accordingly;
- We are providing full compliance with the regulatory requirements;
- Qualified Person Responsible for Pharmacovigilance and his back-up is always in touch;
- We are available for you 24\7;
- Checking youк Company’s readiness for audits and inspections.
Monitoring of scientific and medical books and periodicals as well as regulatory agencies web-sites and other internet-resources so that you might be aware of the latest information regarding your products:
- We can monitor any country where your products are registered;
- Transparency and traceability;
- We may use either our or your SOPs.
Development and implementation of Pharmacovigilance Unit in your company:
- We can either develop the whole thing of your Vigilance Unit or may assist at any stage;
- Delivering the full compliance with the regulatory requirements;
- Committed to enhance quality of your SOPs, logs, forms, and etc., as per your Quality Management System;
- Train with MegaLek! We provide focused, comprehensive trainings and documentation, which leads to a successful trial.
Medical Data Management within clinical trials:
- Data monitoring with medical evaluation;
- Cooperation with Safety Data Monitoring Committee and medical unit of Sponsor
- AE and SAE Data Management and evaluation.
We are also good in:
- Risk Management Plan for registration dossier;
- PV Master file maintenance;
- Periodic Safety Reports development;
- PV unit audit;
- Assisting in preparation for audits of central offices and regulatory inspections.
- Cooperation with regulatory agencies.