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Consultancy

Our customers possess the viable possibility to choose expertise from an extensive range of consultants to match their needs and reach a successful design and analysis of Clinical trials.

Due to our biostatistical heritage, FTH has been an industry leader in European biostatistical consulting for over 20 years: enabling our clients to have the ability to choose expertise from a range of consultants to match their needs and reach their Clinical Trials submission, publication and/or research goals. This solid experience among our staff allows us to provide our clients the needed expertise for their projects: from study start up through to the final analysis, from Phase I to submission; our statistical consultants are among the leaders in their respective areas across different global regions.

We offer EU and Global Consultancy services in 4 different areas:

Clinical Study Design:

  • Writing Statistical Sections of complex protocols

  • Exploring use of Novel Designs across Drug Development Program (DDP)

  • Conducting simulations to estimate and optimize Study Sample Size

  • Support planning of Adaptive Trial Designs, Group Sequential Trials and Related Stopping Rules for Interim Analyses

  • Expert statistical support for Biosimilars and Data Safety Monitoring Boards (DSMBs)

  • Maximizing study efficiency through best statistical practice, including Bayesian Methods

  • Specialist expertise in Pharmacokinetic Analysis and Reporting

  • Exploiting data sources from latest technologies such – i.e. wearables and ePRO solutions

  • Consultancy and Project Management and SOP Development

Risk Based Approaches & Regulatory Submissions:

  • Data Quality Oversight through the generation of Statistical Monitoring Reports (SMPs)

  • Local and Regional Based Regulatory Support, including an independent review of submission dossiers

  • Development of Protocols and SAPs for a Risk-Based Approach to Monitoring

Alternative Trial Types:

  • Registry Studies

  • Health Economics and Outcomes Research