clinical services

 

medical writing We provide all medical writing needs by experienced medical writers with PhD degrees in life sciences and over 10 years of experience. These services include study-specific documents and development-program documents, such as the study Protocol, Informed Consent Forms and the Clinical Study Report.

 

finance We are responsible for the overall construction of a project's budget. This includes forming the study budget plan, negotiation with the sites, executing site contracts and handling site payments throughout the study.

data management We manage all aspects of your data – from study Clinical Data Management Plan Development, through Clinical Data Review and Query Management and until Database Lock Procedures. We strongly adhere to the industry standards by complying with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC).

 
 

study design & planningOur team offers early-stage support and risk mitigation, with focus on cost-effective solutions that reduce development cycle timelines. This includes protocol design, efficient feasibility process, expedited study start-up phase and development of a strategic enrollment and retention plan to adhere to study goals.

 

biostatisticsOur expert biostatisticians offer flexible and innovative solutions for clinical research. With strong scientific backgrounds and in-depth clinical and regulatory experience, our team understands the scientific issues, anticipating and overcoming potential challenges specific to your clinical trial.

monitoring & project management Study Managers assigned to the study will lead the dedicated project team and ensure that the trial is conducted according to plan, with high quality, within timelines and cost effectively. Our team will manage all operational aspects, including source data verification and monitoring activities, ensuring compliance with the ICH-GCP and regulatory requirements.

 

** Pharmacovigilance and Medical Monitoring services are provided through selected partners or external providers.

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