Clinical Trial Services

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Clinical Trial Services

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What is a contract research organization (CRO)? According to the definition of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), a CRO is: “A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.”

A Contract Research Organization (CRO) is a company that provides clinical trial services for the pharmaceutical, biotechnology, and medical device industries. There are different types of CROs, but typical CRO services in the medical device industry include regulatory affairs, clinical trial planning, site selection and initiation, recruitment support, clinical monitoring, data management, trial logistics, biostatistics, medical writing, and project management.

The ICH Guideline for Good Clinical Practice (GCP) specifies the responsibilities of the sponsor via CRO:

  • A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
  • Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).
  • Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
  • All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.

OUR CRO SERVICES
Project Management, including developing and tracking study timelines, ensuring all activities are within scope and budget, coordinating and executing Clinical Trial activities and acting as the central point of contact for the client.
Clinical Monitoring, including protocol, informed consent, submission to the IRB, regulatory and ICH GCP compliance, site personnel training a: assisting and ensuring appropriate reporting to the IRB / Regulatory by the study sites or on behalf of the sponsor. Not limited to Site recruitment strategy, feasibility visits, Regulatory document preparation and collection and Study closure.
This is important to ensure that your trial runs as smoothly as possible. Our clinical project management team has experience managing trials ranging from cell and gene therapies, oncology trials, vaccine trials, medical devices, cohort studies and patient registry.
Quality Assurance / Control, including clinical study document review, accompanied site visits and inspection preparation site visits. Initiation and management of CAPA.


Outsourcing Services
  • Randomization and sample size calculation
  • Biostatistics
  • Medical Writing
  • Medical Consulting
  • Clinical Supply Chain Management
  • E-Patient Diary
  • Logistic including arrangement of logistic for patient management