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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  • Are Outdated Pricing Models Hurting Clinical Research?
    Are Outdated Pricing Models Hurting Clinical Research?

    Two issues that always seem to throw a wrench into sponsor/CROs relationships are changes to staffing and pricing. Protocol changes can disrupt trials for CROs and cause price increases for sponsors. Staffing changes can create new learning curves, delay trials, and cause sponsors to feel they were misled. Are penalties an easy way to fix both?

  • Clinical Staff Shortage: “Growing Plague” For Pharma & CROs
    Clinical Staff Shortage: “Growing Plague” For Pharma & CROs

    Anyone involved with clinical trials knows a continuing and growing problem in the industry is the lack of qualified clinical research staff. A new report from BioPharm Insight (BPI) acknowledges this trend, noting the staff shortage is a “growing plague to the CRO industry which will need to be addressed in order to ease liabilities.”

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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.

  • 10 Insider Tips For eCOA Implementation
    10 Insider Tips For eCOA Implementation

    If your organization has yet to adopt the use of eCOA (electronic clinical outcome assessments) in your clinical trials, then this white paper on successfully implementing the use of this technology should be of interest to you.

  • CROs And The Clinical Supply Chain – It’s Not Just A Label On A Box
    CROs And The Clinical Supply Chain – It’s Not Just A Label On A Box

    Typically Clinical Research Organizations (CROs) involvement in the clinical trial process has centered on site management in terms of identifying potential sites and managing patient recruitment. They also offer services related to activities such as protocol development, data management, laboratory services, and toxicology analysis amongst others. Managing clinical supplies has always been seen as a backroom activity, one which sponsors tended to keep a firm hold on, perhaps highlighting their importance to the sponsor in terms of meeting First Patient In (FPI) deadlines.

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SERVICES AND PRODUCTS

Medical & Regulatory Affairs 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.

Strategic Resourcing Functional Services Strategic Resourcing Functional Services

Our dedicated functional teams have the experience to be your partner in clinical research. We deliver a variety of clinical development services customized to fit your objectives, whether you need a single function across several drug programs, a range of functions within a single therapeutic area, a complete staff lift-out or any other defined need.

Phase I-IIA Clinical Trials Phase I-IIA Clinical Trials

inVentiv Health conducts Phase I-IIa clinical trials quickly and efficiently at its dedicated 22,000 square foot clinical facility comprising more than 200 beds in four independent units. An extensive database and relationships with leading hospitals ensures rapid recruitment of study participants for a wide variety of trials.

Oncology Clinical Trials Oncology Clinical Trials

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

Phase IIb-III Clinical Trials Phase IIb-III Clinical Trials

With decades of experience in clinical trial design, 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.

Central Laboratory Solutions Central Laboratory Solutions

Remember the time when laboratory kits were ordered and reordered by sites faxing in pieces of paper, and laboratory reports were faxed and express mailed to investigative sites around the world? Sadly that time is still here for many central laboratory providers.

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