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Clinical Research Consultancy

Access robust scientific, clinical and regulatory expertise.

High level consultancy solutions supporting early phase clinical trial development and execution.

Investment in comprehensive clinical research consultancy services helps drug developers deliver project efficiencies through best practice and thorough preparation for regulatory approval by Health Authorities (HAs).

We offer strategic solutions to help developers take informed decisions throughout the planning, implementation and delivery stages of a research trial. Our flexible multidisciplinary teams include clinical pharmacologists, medical directors, regulatory affairs specialists, statisticians, clinical operations leads, medical writers and experts in a variety of therapeutic areas.

We support:

  • Building early phase clinical development plans (CDPs) to meet strategic goals
  • Early phase study design development and synopsis/protocols (CTPs) writing
  • Official regulatory documents preparation – e.g., investigator’s brochure (IB)
  • Regulatory interactions – scientific advice, discussions, answering HA questions, etc.

SGS is recognized as the benchmark for quality and integrity in clinical research. We have helped multiple small to mid-size biotech and academic groups during the development of drug products. Whatever your area of interest, we support you with clinical research consultancy services that optimize trial outcomes.

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  • SGS Romania S.A.

38, Calea Serban Voda,

sector 4, 040212,

Bucharest, Romania