Clinical Monitoring Services & Products

  1. 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.

  2. Medical & Regulatory Affairs

    Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.

  3. Biostatistical Services

    Delivering high-quality and accurate data analysis, SynteractHCR is a contract research organization that provides robust and customized biostatistical services tailored to your study’s needs. At SynteractHCR, we believe that a statistician is a vital component in the clinical development process. Working as your partner, SynteractHCR’s expert biostatisticians will review your study’s needs and determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our team is trained to provide creative thinking and analysis optimized for your unique study designs. We provide access to your data in a format well-suited to your project requirements.

  4. Oncology Clinical Trials

    The unique patient populations, study design challenges, and special endpoints associated with oncology trials demand specialized knowledge.  INC Research/inVentiv Health's Oncology team is uniquely qualified to manage that complexity.

  5. Phase IIb-III Clinical Trials

    With decades of experience in clinical trial design, INC Research/inVentiv Health offers a full range of clinical trial services including bioanalysis, biostatistics, data management, feasibility studies, global safety and pharmacovigilance, medical writing, project management, protocol and case report form design, quality assurance, regulatory affairs, risk management, site management, strategic planning, and study monitoring.

  6. Global Multilingual Call Center

    TransPerfect's device-independent call center solutions allow you to easily and affordably route calls to our global call centers where we intake and process cases, either as part of a clinical trial or in supporting post-marketing pharmacovigilance efforts (adverse events, medical information, product complaints, patient registries, etc.).

  7. Merge CTMS For Sponsors & CROs

    Merge’s web-based trial management tools centralize your operation’s essential study details and provide easier access anytime, anywhere.

  8. Cryoport Data Monitoring & Analysis

    Today, there is more focus than ever on temperature monitoring. With increased fragility of biologics and increased scrutiny on maintaining temperature budgets, it is critical that frozen shippers not only maintain their temperature budgets but also have the data to prove it.

  9. CRISTal - Clinical Research Interactive Selection Tool

    CRISTal is RDP Clinical Outsourcing’s proprietary software platform that facilitates the strategic identification of sites, as well as our highly experienced regional monitors.

  10. Central Laboratories: ICOLabs™ & Data Services

    ICOLabs™ is a secure, web-based information system that offers project managers and clinical monitors an easy-to-use, yet powerful, tool to obtain test results, monitor study progress, observe clinical trends and obtain custom reports.