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 of medical monitoring.
As your partner in enabling patient safety and managing enrolled patients safely through the duration of your study, we can provide a forward-thinking approach and a coherent safety data plan.
Then, biostatistics services collaborates with you and clinical trial sites to effectively capture and analyze safety data, identify data interrelationships, and proactively uncover adverse event trends.
We know that challenges related to clinical research vary significantly by disease type and state. So we offer you expertise across a broad spectrum of therapeutic areas, including hematology, vaccines and infectious diseases, ophthalmology, neurology, substance use, oncology, and cell/gene therapies.
And because we aim to ensure study safety and provide the strongest case for your regulatory submissions, we also set out to give you the confidence you need to proactively assess and address your unique safety challenges.
Pharmacovigilance
Our Pharmacovigilance team of experienced clinical professionals, is focused on optimizing your early clinical development or pivotal clinical research.
And we can deploy our state-of-the-art Advantage eClinical data management platform to ensure that all potential/actual safety events and observations are captured, recorded, reported, and analyzed individually and in aggregate.
We are 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.
In addition we are ready to deliver the full scope of services in the area of postmarketing pharmacovigilance services related to marketed products, including maintenance of local PV system, case management, literature monitoring, preparation and implementation of risk mitigation activities, etc.
Pharmacovigilance
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
Pharmacovigilance training
Label changes for pediatric populations as per the Best Pharmaceuticals for Children Act (BPCA)
Medical Monitoring/ Medical Consultancy
Our MDs’ extensive clinical development experience can help your team to navigate an entire program.
Emmes Medical Officers drive success through every step, from pre-IND requirements through end-of-phase 3. That includes advising clinical programs, drafting and reviewing key clinical documents from study execution to filing.
Our team of Medical Officers provides broad spectrum of services, including real time medical review, periodic medical review, medical consultancy, medical communication, medical training, etc.
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
Pharmacovigilance and Medical Monitoring Leaders
Ondrej Krejci
Vice President,
Pharmacovigilance
and Medical Monitoring
Vice President,
Pharmacovigilance
and Medical Monitoring
Vice President,
Pharmacovigilance
and Medical Monitoring
Bettae Rodgers
Senior Director,
Global Pharmocovigilance
& Medical Monitoring
Senior Director,
Global Pharmocovigilance
& Medical Monitoring
Senior Director,
Global Pharmocovigilance
& Medical Monitoring
Schedule a Meeting
Please contact us
Factsheet
Emmes General Capabilities Factsheet