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FEATURED ARTICLES

  • Are You Correctly Conducting Your CRO Qualification, Oversight, And Audits?
    Are You Correctly Conducting Your CRO Qualification, Oversight, And Audits?

    David Kim has spent most of his career working on clinical trials. His areas of expertise include implementing strategic alliances, leading and directing sourcing and vendor management teams, and partner negotiations. In this interview with Clinical Leader, Kim discusses the challenges of CRO qualification, oversight, and audits, and how to make sure you are not being overcharged for the work you outsource.

  • Are Your Cell Therapy Samples Getting The Preservation They Deserve?
    Are Your Cell Therapy Samples Getting The Preservation They Deserve?

    With the number of biologics now in development and soon to be making their way into clinical trials, the preservation of cells, tissues, and organs are suddenly increasing in importance. Companies handling the manufacturing, storage, and transportation of these materials need to be focused on improving the yield and extending the shelf life of these time and temperature sensitive biologics.

  • Which Clinical Conferences Are Worth Your Time?
    Which Clinical Conferences Are Worth Your Time?

    If you are like me, you get bombarded with clinical conference promotions on a daily basis. In an age where we are inundated with electronic interactions, connecting with individuals face-to-face has become a rarity. While conferences enable that interaction, job requirements limit your out-of-office opportunities. So how do you decide which clinical conferences are worthy of your time?

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WHITE PAPERS AND CASE STUDIES

  • SynteractHCR Full-Service CRO Brochure

    SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.

  • Risk-Based Monitoring - Can You Afford To Wait?
    Risk-Based Monitoring - Can You Afford To Wait?

    On-site monitoring is one of the largest cost drivers in a trial, accounting for 30 percent on average of the cost of a clinical trial. Fifty percent of the cost of on-site monitoring involves ensuring data quality through source document verification (SDV).

  • Financial Management With Clinical Conductor Site CTMS At Coastal Carolina Research Center

    The Coastal Carolina Research Center began using Clinical Conductor Site CTMS in 2008.

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SERVICES AND PRODUCTS

Clinical Operations 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.

Risk Mitigation: Gap Analysis Risk Mitigation: Gap Analysis

Global regulators are becoming increasingly vigilant in their oversight of clinical research, steadily increasing the annual number of Sponsor inspections they conduct. Sponsors that proactively assess process and organizational risks can act before these risks become findings in a regulatory inspection.

Therapeutic & Diagnostic Product Strategy Development Therapeutic & Diagnostic Product Strategy Development

As products evolve and change, so does the expertise required to develop them. We work with the new and growing field of therapeutics and diagnostics that are combination products, typically comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic. These products can be physically, chemically, or otherwise conjoined to produce a single entity; packaged together in a single package; or labeled in such a way that both products are required to achieve the intended use or effect.

Late Stage Clinical Product Development Strategy Late Stage Clinical Product Development Strategy

Our deep expertise in translational and clinical sciences combined with strong operational background allows us to evaluate each client's assets as unique commercial opportunities. We guide our clients through critical strategic decisions at product transition points, and help them manage partnerships or other collaborative alternatives.

Biopharm & Medical Device Vendor Management Biopharm & Medical Device Vendor Management

In today's environment, companies are focusing on optimizing costs and as such, utilize external vendors frequently. However, with organizations increasingly dependent on multiple vendors to support product development, a disciplined approach to vendor management is critical for success.

Organizational Design And Development Organizational Design And Development

Organizational optimization is one of our core offerings. We help clients redefine the vision for their company, restructure for a long-term and sustainable change, or build specific strategic and tactical capabilities to accomplish their product development objectives.

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