MD Pharma Consulting Group

We provide pharmacovigilance services for pharmaceutical, biotech and medical device studies and post market surveillance activities.

Services include assessment of seriousness, causality, and expectedness, documentation within clinical EDC systems and safety management applications, reconciliation between systems as well as generation, submission and tracking of regulatory forms such as MedWatch and CIOMS.

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We provide comprehensive Medical Monitor and Data Management Services including preparing medical monitoring audit checklists, site initiation visits, protocol training, on-site and remote monitoring visits. 

We work with our Sponsors to develop eCRFs based on protocol requirements, provide complete data management services, develop clinical safety programs, conduct medical and drug coding with MedDRA and WHODrug dictionaries, and provide complete oversight of site query management.

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We provide complete Medical Writing services for clinical study protocols, informed consent, medical coding conventions, safety management specifications, medical management and safety plans, white papers, investigator brochures, training materials, SAE narratives, IND safety reports, and Data Safety and Monitoring Board (DSMB) summaries and updates.

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We choose the right statistical tools and deliver accurate interim, end of trial, and post-hoc analysis of your clinical study results to reflect true efficacy outcomes.

We provide full analysis for Safety, Survival, Health Economic and Biomedical Research Outcomes.

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Our scope of drug and medical device R&D services for your Investigational New Drug and Investigational Medical Device include Pharmacokinetics, Pharmacodynamics and Pharmacokinetic/Pharmacodynamic Modelling, Bioinformatics, and Toxicology.

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