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Fact Sheets

Benefits of Bionical Emas – Phase 1 Services

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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.

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)


  • 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% 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.