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Highly experienced drug development consultancy to guide you through the different phases of clinical development.

Stetoscope

During the clinical development process, you need an experienced partner with the expertise and resources to ensure every phase runs smoothly. As a world leader in life science services, we have over 35 years’ experience as a global contract organization. We shape our early drug development consultancy services to meet your exact needs – from working on single compounds to leading a full drug development program.

We have designed numerous, innovative early phase clinical development plans and study designs which obtained subsequent approval. Our dedicated multi-disciplinary team can support your global development strategy, offering essential regulatory, toxicology, pharmacology and therapeutic expertise.

Trusted drug development consultancy services from a world leader 

We offer you extensive knowledge, gained from our work with regulatory agencies worldwide, and our unique early phase clinical trials background with big pharma and small biotechs. Our experts are trained to meet the requirements of international guidelines, such as GCP, ICH, EMEA/CPMP, the FDA and other important regulatory bodies.

We also offer development coaching, focusing on a high-level overview of your file to guide you to the required development steps for optimizing your compound.

Our comprehensive range of services includes:

  • Early phase development strategy and tactics:
    • Regulatory strategy
    • Candidate selection: early characterization, formulation and stability testing, review of pre-clinical data/reports
    • Lead optimization: CMC, non-clinical and clinical development plans
    • Target Product Profile (TPP) 
    • Set-up and participation in Scientific Advisory Boards
    • Study design and clinical study protocol writing
    • Due diligence and opportunity assessment
  • Validation of strategy with regulators:
    • Scientific advice meetings with the European Medicines Agency (EMA) and European National Agencies
    • Pre-IND and End of Phase meetings with the Food and Drug Administration (FDA)
    • Support in discussions and preparation of answers to agency questions
  • Development and redaction of official health authorities’ trial documents: 
    • Writing and development of Investigational Medicinal Product Dossier (IMPD) and Investigators Brochure (IB)
  • Scientific and medical input

We are the partner of choice for a wide range of biotech companies who rely on our expertise to support them, answer the complex requirements of health authorities, and successfully perform IND and CTA submissions. We offer you:

  • Worldwide recognized expertise in early phase clinical trials 
  • Experience in all clinical development stages
  • Full access to in-house experts working as a team rather than as individual consultants
  • The capability to translate strategy into tactics and solid data for dossiers
  • A client management policy that focuses on the importance of your requirements 

To discuss and establish your drug development plan, contact us today.

Stethoscope

Early Phase Clinical Trials Maxims

Discover the early phase clinical trial drug development fundamentals through our Maxims.

Download the Maxims