Benefits of Bionical Emas – Phase 1 Services.

A guide to the specialised clinical research services, provided by Bionical Emas, in support of a successful delivery, for Phase 1 clinical studies.

Outline.

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.

Clinical Operations.

• 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)

Pharmacovigilance.

• PVG Study documents
• SIV Training
• Safety database set-up and management
• SUSAR reporting

Medical Services.

• Protocol development
• Clinical study reports
• Safety and medical monitoring
• Establish and run Data Monitoring Committees (DMC)

Additional Services.

• Regulatory services
• Clinical trial supply

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.