Phase I Consultancy

Early phase clinical development is a critical milestone in drug development. Optimizing your phase I strategy is essential for ensuring the success of your drug development project. SGS offers phase I planning and consultancy services to help you design and develop your phase I strategy, so you can reduce risks, ensure regulatory compliance and make informed decisions, ensuring you are well positioned for the next development stages.

Strategic phase I planning

Our structured approach helps you transition confidently from pre-clinical research to first-in-human (FIH), proof of concept (POC) and patient trials. We will assist you with:

Phase I strategy
Study design and development
Risk mitigation and compliance

Ensure your phase I studies are well designed, practical and cost efficient

We ensure that your studies are not only scientifically rigorous and compliant, but also operationally feasible, in line with your budget restraints, participant logistics and development goals.

Define the right strategy
We help you to develop a clinical development plan (CDP) and target product profile (TPP) that is tailored to your compound and shaped around your company’s specific ambitions.
Design and develop
Get support with your study synopsis, protocol design, patient recruitment, investigator brochure (IB) creation, and the design and implementation of adaptive or hybrid trials.
Optimize your finances
We offer flexible solutions tailored to your financial capabilities. Our financial planning services enable you to ensure your study scope is within your budget and get a POC to secure funding.
Meet documentation requirement
Our comprehensive medical writing service supports your documentation needs from study synopsis to protocol development, in alignment with global health authority expectations. We prepare regulatory dossiers, including IND, CTA, IMPD and IMB submissions.
Reduce risks and ensure compliance
We help you to coordinate scientific technical advice (STA) with EMA, FDA and national regulatory agencies, evaluating modeling and simulations and providing up-to-date insights on country-specific regulatory requirements. We have extensive experience with EU regulatory landscapes.
Protect your intellectual property
Your IP remains fully protected under CDA/NDA, even if you choose not to proceed with SGS.

Early phase drug development support from a leading provider of clinical research services

We have over 40 years’ experience as a mid-size, full service CRO along with extensive phase I experience and deep scientific knowledge of investigational compounds. Our team of clinical pharmacology, regulatory affairs, biostatistics and medical writing specialists are on hand to provide their expertise and strategic guidance. With our own clinical pharmacology unit (CPU), we have access to cutting-edge methodologies and can reduce delays and optimize outcomes.