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Phase I – III

Clinical research excellence

The early phases of your product’s development are critical to its success. You need experience, agility, and resources: you need TFS HealthScience.

Strategic approach to phase I – III clinical trials

TFS offers a full suite of clinical services and functional solutions on a global, regional, and local basis. Our global reach, focused therapeutic experience, client-centric approach, and robust technology are strong pillars supporting your clinical trial success. At these stages, we enlist therapeutic and regulatory experts to build a customized strategy to meet your goals and select the best path forward.

Access to world-class senior medical and clinical advisors, guide the protocol development process and study conduct, adding to the efficiency of our services.

 

Early Phase I – II and specialized expertise includes:

  • First-in-human and proof-of-concept
  • Micro-dosing
  • Single Ascending Dose/Multiple Ascending Dose (SAD/MAD)
  • Drug-Drug and Food-Drug interaction
  • Flexible trial design, e.g., adaptive, basket/umbrella trial
  • Biosimilarity/Bioequivalence
  • Regulatory affairs strategy, preparation, and submission of CTA/ITA, PIP, IND, PMA/510(k)
  • Pharmacokinetics/
    Pharmacodynamics (PK/PD)
  • Pet imaging
  • Bioanalytical
  • Pediatric populations
  • Elderly populations
  • Rare disease and orphan indications
  • Medical devices
  • Customer access to executive level oversight with our TFS Governance model

Phase II/III

TFS provides full-service capabilities for phase II/III trials and pivotal studies for a range of drugs, biologics, and devices, across a large number of therapeutic areas. Each customer receives the same dedication and attention to detail.

  • A dedicated project manager is assigned to each project in agreement with the customer
  • Communication is continuous and transparent
  • A comprehensive project kickoff and planning process is conducted with built-in flexibility to adapt to changes, as needed, throughout your trial
  • Study initiation services and a network of trusted investigator sites for accelerated study start-up are accessible
  • Robust electronic data capture (EDC) systems combined with our clinical trial management system (CTMS) and clinical analytics ensure data integrity throughout your trial
  • A real-time review of EDC metrics is available through our customer portal

Implementation with agility and accuracy:

Best-in-class access to the targeted patient population required for each study
Flexibility to benchmark multiple sites in each proposal, ensuring highest-performing sites for your trial
Depth of therapeutic area experience—our operations, medical advisors, QA, and project leads improve the quality and speed of your clinical development

How we work
The TFS advantage

  • We become your partner from the moment of contract award to delivery of the clinical study, implementing a ‘fast-track’ mentality throughout: delivering on time, within budget, and with the highest quality
  • In addition to your dedicated account and project manager, you will have direct line access to our senior leadership
  • Our teams, located in more than 20 countries, possess local expertise and cultural sensitivity

We have the right people and right solutions to help you on your path to success. Let’s talk today.

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