Clinical Operations
Clinical operations are a critical component in all studies. SynteractHCR’s highly skilled staff is well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study. From start-up to close-out, experienced clinical managers and clinical research associates (CRAs) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.
We offer a wide network of experienced monitors throughout Europe, the USA and Israel. Today's requirements for global development programs are served by our alliance with long-established partners in Japan, India and Latin America. We can offer you direct access to research activities in the world's key markets with a consistent high standard of quality meeting ICH-GCP guidelines.
Whether helping your organization handle an overload of work on a single project or designing a full-service clinical program for your product, SynteractHCR’s clinical trials management team has experienced knowledgeable staff members ready to assist you.
- Clinical services custom-tailored to fit your needs
- Study document development
- CRA management and quality control
- Clinical monitoring and site management
- Clinical trial management system
- Global investigator meeting planning (via Web)
- Third party vendor management
- Audits and preparation for FDA audits
- Training
- Patient recruitment and retention strategies
- Worldwide feasibility studies
- Quality training of clinical associates
CRAs undergo a thorough instructional regimen and are trained on SynteractHCR’s clinical standard operating procedures, clinical guidelines, and monitoring tools. In addition, clinical team members are educated on FDA regulations, ICH guidelines, and local regulations related to clinical trials, as well as good clinical practices. These educational processes, along with protocol-specific training prior to the first monitoring visit, ensure your study will deliver the quality outcomes you expect.
Responsible Trial Monitoring Handled by Experts
SynteractHCR’s clinical trial management team can conduct feasibility studies around the globe utilizing our knowledge of appropriate investigative sites supplemented with data from our global partners. We help ensure the right investigational sites are identified, facilitate coordination of regulatory submissions with our regulatory group and sponsor personnel, and manage the monitoring process both domestically and globally. We’ll set up and maintain the Trial Master files and will define a monitoring plan that supports the study design. By anticipating and resolving potential problems early, our clinical operations group keeps studies on track.
Our highly experienced CRAs serve as the primary point of contact for the study sites. They are responsible for monitoring and managing a site's activities throughout the clinical study, including performing site qualification, initiation, interim and closeout visits. We provide our CRAs with all the tools they need to ensure monitoring and site management activities are consistent and of the same high quality across all of our projects.