Clinical Safety and Pharmacovigilance
The clinical research your organization conducts has the potential to deliver lifechanging medical advancements. To do so requires dedicated and minutely detailed management of clinical trial safety risks.
At Emmes, we understand the importance of patient safety to our clients and the assurance of managing enrolled patients safely through the duration of your study. We aim to provide you with a forward-thinking approach and a coherent safety data plan. Then in collaboration with you and clinical trial sites, we ensure that you effectively capture and analyze safety data, identify data interrelationships, and proactively uncover adverse event trends.
Safety issues can vary significantly by disease type and state, requiring expertise across a broad spectrum of therapeutic areas. With experience in hematology, vaccines and infectious diseases, ophthalmology, neurology, substance use, oncology, and cell/gene therapies, Emmes can provide you with the confidence you need to proactively assess and address your unique safety challenges. Our ultimate goal is to ensure that your study is safe for patients and provides the strongest case for your regulatory submissions.
To optimize your early development or pivotal clinical research, Emmes’ Safety and Pharmacovigilance team, comprising experienced physicians, nurses, and other clinical professionals is here to support you. We will employ 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. Sharing your ethical passion for patient health, our protocol review and safety and medical monitoring is focused exclusively on helping you achieve your clinical study goals while protecting human subjects.
At Emmes, we see ourselves as an extension of your team, sharing the same dedication to bringing new therapies to patients who need them. From Phase I-III clinical development research to Phase IV post-marketing studies, Emmes’ pharmacovigilance services team collaborate with you to achieve your clinical development and regulatory objectives. Our approach is to meticulously plan what will be needed for the safety summary by first looking at your BLA or NDA submission goals and providing an agile path to attain them
There are many potential paths in the clinical development process to achieve your specific goals (e.g., speed to market, specific label claims). We believe that building a full clinical development plan means first understanding your end goals and then proactively planning an optimized path with informed “checkpoint” decisions to reach them.
We strive to help you predict the challenges that may impact regulatory aspects of your study and to nimbly address issues through the lens of the ultimate registration packet.
Emmes offer a variety of safety and pharmacovigilance services to clients to support your product development plans while assuring the safety of patients.
Clinical Trial Safety
- 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 WHODrug coding
- Literature searches
- RMP development
- ISS and ISE development
- 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 agreements
- 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)