Detailed Safety Management. Built for Confident Regulatory Submissions
To deliver life-changing medical advancements, the clinical research you put into global drug development requires dedicated and detailed management of clinical trial safety risks and high-quality medical monitoring.
Pharmacovigilance

Our Approach
Our pharmacovigilance team of experienced clinical professionals is focused on optimizing your early clinical development or pivotal clinical research.
We deploy our state-of-the-art Advantage eClinical data management platform to ensure that all potential and actual safety events and observations are captured, recorded, reported, and analyzed individually and in aggregate.
We're your partner in patient health, and our protocol review and safety and medical monitoring are designed to help achieve your clinical study goals while protecting human subjects. We also deliver the full scope of post marketing pharmacovigilance services related to marketed products, including maintenance of local PV systems, case management, literature monitoring, and preparation and implementation of risk mitigation activities.

Our Services
Safety monitoring plans
Real time monitoring of safety data
SAE narrative construction and follow-up
Case reporting for SAEs
Literature monitoring in local language
Risk minimization activities/risk management plans
Post-Authorization Safety/Efficacy studies (PASS/PAES) development
Case processing
Event trend and signal detection services
MedDRA and WHO Drug coding
Therapeutic area and clinical development consulting
Global safety report drafting and submissions, including aggregate safety reports
Submission and follow-up with regulatory authorities
Pediatric investigation plans
Integrated safety summaries
Pharmacovigilance System Master File (PSMF)
National Person Responsible for Pharmacovigilance (NPRP) within Europe
Pharmacovigilance audit and training
Label changes for pediatric populations as per the Best Pharmaceuticals for Children Act (BPCA)

Medical Monitoring and Medical Consultancy
Our MDs' extensive clinical development experience can help your team navigate an entire program. Emmes Medical Officers drive success through every step, from pre-IND requirements through end-of-phase 3, advising clinical programs and drafting and reviewing key clinical documents from study execution to filing.
Our team of Medical Officers provides a broad spectrum of services, including real-time medical review, periodic medical review, medical consultancy, medical communication, and medical training.
Advising clinical programs
Development of study specific documents (Protocol, CRF, ICF, etc.)
Development of Medical Monitoring Plan
Medical review of AEs, SAEs, lab data
Patient eligibility assessment
Individual protocol deviation assessment
Medical review of coding (MedDRA; WHO)
Medical review of safety update reports, CSR input
Medical training
Medical communication


Let's Connect
Schedule a Meeting
Let's discuss how our pharmacovigilance and medical monitoring expertise can support your next study.
- Speak with a pharmacovigilance expert
- Tailored solutions for your study needs
- Quick and easy scheduling
Resources
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