A guide to the specialised clinical research services, provided by Bionical Emas, in support of a successful delivery, for Phase 1 clinical studies.
Phase I clinical trials are a key step in any pharmaceutical company’s clinical drug development process. Phase I studies are undertaken in dedicated units and those Phase I units typically provide services, centred around the volunteer. However, there are additional activities, outside of the interaction with the volunteer, that are required for a Phase I study to be successful. This is where Bionical Emas can be of help.
- Data monitoring undertaken by a specialist Phase I Clinical Research Associate (CRA) team. Monitoring can be undertaken on site or remotely
- Study Project Management
- Document management including Electronic Trial Management File (eTMF)
- PVG Study documents
- SIV Training
- Safety database set-up and management
- SUSAR reporting
- Protocol development
- Clinical study reports
- Safety and medical monitoring
- Establish and run Data Monitoring Committees (DMC)
- Regulatory services
- Clinical trial supply
Bionical Emas extensive experience with specialist Phase I units.
20+ years Experience working on Phase I studies and working with specialist Phase I units in the USA, Europe and Asia Pacific
60+ Supporting over 60 Phase I studies a year
35 Supported over 35 different therapeutic areas
100% 100% SDV (Source Data Verification) of data for over 2000 patients
Benefits of using Bionical Emas.
- An experienced, established and dedicated Phase I team, experienced in managing the rapid start up timelines of Phase I studies. From contract to Site Initiation Visit (SIV) within two days
- A cost-effective business model tailored to meeting the specialised requirements of Phase I studies
Bionical Emas is the only Clinical Research Organisation (CRO) that provides services to support, clinical drug development, early access programs and clinical trial supply.
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