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.
Jaroslav Vydlak
We look forward to talking with you, learning more about your specific goals and determining how we can help you.
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 harmacovigilance 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.
Medical Monitoring/Medical Consultancy
- 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
