Our strength is rapid patient enrollment that stems from local knowledge.
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- 1000+
- Clinical studies
- 20
- Years' experience
- 32%
- Oncology
- 18
- Countries
Drug Development
Regulatory
Pharmacovigilance
Data Management & Biostatistics
Medical Device Development
Emmes' Rare Disease CenterEmmes is a full-service CRO
Emmes’ operations in Europe have proudly contributed to the advancement of medical research for almost two decades. With the 2020 acquisition of Neox s.r.o., a European-based CRO, we have expanded into 18 countries on the continent and the UK. A few months later, Emmes acquired Orphan Reach, a UK based CRO dedicated to clinical research in rare diseases. This local knowledge and niche expertise enable optimal country selection for clinical trials, rapid enrollment, tailored monitoring, and regulatory expertise.
Message fromPavel MarekManaging Director
Emmes Europe
Emmes’ operations in Europe have proudly contributed to the advancement of medical research for almost two decades. With the 2020 acquisition of Neox s.r.o., a European-based CRO, we have expanded into 18 countries on the continent and the UK. A few months later, Emmes acquired Orphan Reach, a UK based CRO dedicated to clinical research in rare diseases. This local knowledge and niche expertise enable optimal country selection for clinical trials, rapid enrollment, tailored monitoring, and regulatory expertise.
Drug Development
With extensive experience in multiple therapeutic areas including oncology, cardiology, neurology, and gastroenterology, Emmes Europe provides a wide array of clinical research services. We support our clients in several ways ranging from Phase I-IV clinical studies in Europe.
- Medical writing
- Bio-equivalence studies
- Site contracting
- Project management
- Clinical and medical monitoring
- Pharmacovigilance
- Regulatory
Regulatory
Our Regulatory Affairs team are local experts who hold vast experience and extensive knowledge in national guidelines and procedures, key aspects of the local regulatory processes, and documenting management practices.
Regulatory Affairs services for marketing authorizations:
- Centralized, decentralized, mutual recognition and national marketing authorization procedures
- Variations and renewals
- Acts as a liaison with regulatory authorities
- Scientific advice applications
Pharmacovigilance
Effective processing of clinical trial safety data is imperative to both the successful performance of the study and to guarantee post-marketing safety. Emmes offers effective management of clinical trial and post-marketing adverse events from case assessment to expedition, including processing, expedited reporting, periodic safety update reports (PSURs), literature screening and safety signal detection and review.
Data Management & Biostatistics
From clinical development planning to data delivery, Emmes is committed to customizing data management solutions that emphasize accuracy, integrity, accountability, and transparency as much as agile reporting.
Phase IV and Post-marketing – RWE
At Emmes, we understand the complementary relationship of clinical evidence and product value.
Whether you are seeking to demonstrate value to regulators, payers, clinicians or patients, our team of experts in real-world evidence and real-world data can support you throughout the clinical development lifecycle and beyond. As your product seeks market authorization, we can enhance your go-to-market strategy by employing our expertise in clinical, pharmacological, epidemiological, and statistical analysis. From supporting post-marketing commitments to Phase IV studies and clinical trials register in Europe, Emmes is here to help improve your product’s success.
Medical Device Development
We understand the unique requirements of medical device clinical trials. Our dedicated team supports our clients in all aspects of the study, from design to complete trial close-out:
- Drafting investigational plans
- Thorough preparation of all essential documents
- Legal support during contract negotiation
- Intensive and regular communication with regulatory authorities and ethics committees
- Monitoring services
- Development of customized clinical database
- Development of pharmacovigilance system
- Statistical analysis
Emmes' Rare Disease Center
With approximately 7,000 rare diseases affecting 300 million people worldwide, clinical trial research in rare diseases continues to be a top priority for Emmes and many of our clients. While only 5% of rare diseases have an approved treatment, Emmes strives to be at the forefront of groundbreaking research for these small, yet collectively large populations in order to increase the treatments available within the rare disease space.
Our recent acquisition of Orphan Reach, a rare CRO, helps to establish us as an industry leader with regard to clinical research in Europe for orphan and rare diseases. Together, we combine 40 years of research and data experience with a specialized team whose reputation spans across 60+ rare disease trials and 50 biopharma clients throughout the world.
This new and unique offering drives our expert rare disease team to provide continued, seamless, high-quality support to biopharmaceutical companies throughout any stage of the orphan product lifecycle.
We look forward to talking with you, learning more about your specific goals and determining how we can help you.
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