For phase I and IIa clinical studies, Business & Decision Life Sciences provides a cost-effective end-to-end solution, built around the clinical services of a 30-bed phase I and IIa unit. Additional supporting services include protocol writing, operational management and monitoring, clinical data management, statistical and pharmacokinetic analysis, as well as report writing.

Protocol Development

Business & Decision Life Sciences supports the protocol development with clinical, medical writing and statistical services. This includes the design of the study, the formulation of clinical endpoints, sample size and power calculations, protocol writing, etc...

Clinical and Operational Management

The operational project management services include site selection, initiation and training, ethical committee submissions, study document writing and review, study budgeting and follow-up.

• Clinical services are provided by a phase I and IIa unit that performs phase I and bioequivalence studies on healthy volunteers, as well as phase IIa studies involving patients from various therapeutic areas.
• This 30-bed phase I and IIa unit is located on university hospital premises, operates a lab facility for the processing of biological samples and ambulatory treatment facilities.
• It was established in 1997 and is fully GCP compliant. In over a decade, the phase I and IIa unit has gained experience in more than 250 studies across various therapeutic areas.

Clinical Data Management

Business & Decision Life Sciences develops the case report form (CRF), builds the database, and subsequently collects and reviews the clinical data. The data are cleaned using extensive data consistency checks and listings, and are delivered in CDISC format.

Analysis

The biostatistics department creates the statistical analysis plan (SAP), produces the analysis datasets, performs the statistical analysis, as well as the compartmental and non-compartmental pharmacokinetic analyses.

Reporting

Reporting services include the creation of the statistical report, the clinical study report, writing of scientific publications and the investigator brochure.

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