Regulatory & Study Start-up
Your trusted regulatory services partner from discovery through
development to market authorization and product maintenance
Right people, right solutions
TFS HealthScience has extensive experience managing all aspects of regulatory affairs, supporting early phase through clinical development to market authorization and product maintenance. Our senior staff offers more than 30 years of successful submission experience, interacting with regulatory agencies worldwide.
Our services include:
Clinical Strategy & Submissions
- Preparation and submission of European CTAs, including Voluntary Harmonization Procedure (VHP)
- Regulatory strategy & support
- Clinical trial document review, preparation & development support
- ATMP strategy and support
- Orphan Drug Applications
- Pediatric Investigational Plans (PIPs)
Product Maintenance
- SPC/product leaflet/labeling updates
- Support and maintenance of Nordic national databases concerning life cycle events of pharmaceutical products, including FASS
- Variations
Marketing Authorization
- Preparation and submission of marketing applications
- Compilation and submission – all procedures, including Decentralized Procedure (DCP) and Mutual Recognition Procedure (MRP)
- Labeling proposal
One team, one voice
At TFS, you receive a tailored solution based on your needs that includes expertise from a variety of disciplines—project management, regulatory affairs, study start-up, medical informatics, medical writing, and more—all dedicated to your program and working together seamlessly to provide best-in-class support for your study. At the same time, we appreciate that flexibility of approach, adaptability, and clarity of communication are part of an effective collaboration. That’s why one Regulatory Affairs Manager is allocated to a specific trial. They become your regulatory partner, providing a strategy reflecting your unique requirements and overseeing regulatory communication during the process.
Good site selection and initiation is the foundation for a successful clinical trial
Planning
Feasibility & site selection
Submission & CSAs
Agency & ethics queries
Study maintenance
Completion
A dedicated feasibility team, including medical, regulatory, and clinical research professionals, coordinates feasibility surveys for each clinical trial. The team assesses each project’s specific needs, performs a thorough risk assessment, and drives contingency planning, which results in well thought out recommendations and potential alternative scenarios.
For each project, a Feasibility Manager is appointed, supported by a dedicated team of local feasibility specialists to manage local interactions in individual countries. Based on TFS’ previous experience and broad investigator network of key opinion leaders (KOLs) and principal investigators, the team has access to a large pool of sites to involve in study feasibilities across a broad range of therapeutic indications.
Potential investigators are contacted by phone to determine their interest in the study, followed by an initial feasibility questionnaire to assess the study design’s overall feasibility. Feedback from the investigators on inclusion and exclusion criteria, co-medication, study procedures, patient recruitment, etc. helps define the project plan and, where applicable, refines the protocol. It is this proactive approach that helps ensure the success of the project.
The feasibility team follows up and conducts in-depth telephone interviews or sets up face-to-face meetings to discuss study-specific topics in detail to identify and resolve potential challenges that may jeopardize patient recruitment.
Our feasibility expertise:
- Assess the incidence of the indication in specified countries
- Analyze competing trials & compounds in development
- Assess country-specific differences, e.g., regulatory, importation, clinical practice
- Review trial design (by therapeutic experts)
- Design the feasibility questionnaire
- Coordinate and conduct the feasibility survey
- Produce the data-driven feasibility report
TFS’ thorough approach towards feasibility, in combination with patient recruitment services, ensures the selection of high-performing sites and on-time patient enrollment.
Proactive planning, forecasting, and evidence-based recommendations
The goal is clear: the success of the trial. We get there with world-class regulatory experts and data scientists with access to unique resources: immediate ability to query electronic databases on 300,000+ clinical trials, 430,000+ investigators, and 163,000+ sites to support study design, site selection, and patient recruitment, as well as utilizing our exclusive recruitment forecasting model and internal metrics of site, trial, and investigator intelligence databases to support operational planning of studies and programs.