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HomeResource LibraryBenefits of Bionical Emas – Phase 1...

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

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.

How can we support you?

Our dedicated teams of experts are on hand to help should you require any additional resource or further information about our services.