Notre contrôle de la surveillance clinique maintient votre essai sur la bonne voie

The Syneos Health CNS Business Unit is the home of our unparalleled Clinical Surveillance and Training (CST) team, a powerful and specialized business center dedicated to subject and data quality.

 

We ensure data integrity with our specialized in-house Clinical Surveillance and Training (CST) capability - the only one of its kind at a CRO.

La recherche a démontré que les sujets répartis aléatoirement dans les essais cliniques en santé mentale ne répondent pas tous aux critères de sélection rigoureuse que le promoteur avait prévue. High rates of protocol drift, whether they are due to misinterpretation of complex protocol criteria or failure to comply with more straightforward requirements, translate to a study population that provides uninterpretable, non-actionable data.

Our Clinical Surveillance and Training offering is our integrated solution for enrolling the right study subjects in your trials. This global team consists of doctoral-level clinicians and dedicated project managers who conduct holistic, collegial and culturally sensitive eligibility reviews to ensure on-protocol subject selection.  The ever-increasing complexity of CNS research demands unprecedented diligence at the site level, even as budgets get squeezed. Answers based on unambiguous and trustworthy data are crucial to achieving commercial success.

 

Integrated Clinical Surveillance & Training (CST)

Syneos Health is the only CRO with an in-house surveillance and training capability offering customizable services for:

 

  • Rater Training and Certification
  • Scale Management and Translation
  • Eligibility Review
  • Therapeutic Logic Checks
  • Other Customized Services (e.g., protocol writing, study design consultation, scale creation and validation, centralized rating, and other services)

 

Our Clinical Surveillance and Training (CST) offering is our integrated solution for ensuring that:

 

  • The right subjects enter the trial, properly screened for eligibility
  • Electronic source and/or electronic capture of assessment data are seamlessly and accurately integrated with full study data
  • Staff receive the didactic training and certifications needed to rate scales accurately and consistently
  • Scales are managed and translated consistently across languages and linguistically validated
  • Therapeutic logic checks allow timely remediation if scales are administered incorrectly or scored inaccurately at a site or study level
  • Infrastructure and technological skills are in place to monitor and synthesize Patient-Reported Outcomes (PROs) as research becomes more patient-directed
  • Staffing and training solutions are comprehensive and reflect a commitment to ongoing development of operational skills as well as scientific and therapeutic expertise
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