Clinical Support

Full Project Management

Clinical trials are a huge operation, normally involving multiple global teams, vendors, sponsors and logistical challenges. Our clinical operations team has decades of experience of overseeing all aspects of clinical trials to maximise the chances of a positive outcome and completion in the anticipated timeframe. The team is embedded in our business to provide advice, strategy and execution of pre-clinical and clinical trials, they work closely with our development, manufacturing, project management and regulatory affairs team from the start to ensure they have an expert understanding of the drug, its therapy area and intended goals.

Preclinical trial management

We help our clients to design and conduct preclinical general toxicology, genotoxicity, carcinogenicity, reproductive toxicity and safety pharmacology studies to evaluate new biological entities. We then compile the respective reports ready for IND submission.

  • Efficacy
    • Pharmacokinetics (PK) services
      • Dose range finding
      • Drug administration route
      • Sample collections
      • Biodistribution
    • Pharmacodynamic (PD) profiling
    • Toxicity
    • In vitro assay

Clinical Trials

Our clinical trial capabilities include overseeing trials from the pilot and early feasibility studies including first in human to multicenter, global phase III studies, independent whether these are following standard clinical endpoints or sophisticated adaptive designs.

  • Develop clinical trial designs tailored to research goals
  • Design clinical development strategies incl. set up and review clinical protocols including:
    • Determine sample size calculations and target populations
    • Blinding strategies and placebos selection
    • Site and investigator selection
  • Management of timelines, budget, deliverables and data quality
  • Ensuring efficient communication with sponsor, vendor and sites
  • Report writing and reviews for submission

Dedicated Points of Contact

At the start of a project, we dedicate a highly experienced project manager to drive the team.  This project manager will be the single point of contact during the whole course of the project. They provide regular tailored dashboard updates that meet the needs of the project including overall status updates, variance to baseline plan and prior period, critical path and scope adherence.

We are open and honest without exception

We believe transparency in communication is essential for a successful partnership. We report all news, good or bad, immediately to our partners and work rapidly to resolve issues.

We are fully focused on delivering your projects on-time to the highest of standards

Extended Solutions

Project Management

We believe transparency in communication is essential for a successful partnership. We endeavor to report all news, good or bad, immediately to our partners.

Extended Solutions

Quality

Quality, safety and efficacy are adamant fundamentals of our business. Discover how we work towards the highest quality aspirations and review our manufacturing certificates and inspection history.

Extended Solutions

Regulatory Support

We provide regulatory CMC support to our global customers.