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FEATURED ARTICLES

Is CRO Consolidation Good For Pharma?
Is CRO Consolidation Good For Pharma?

Consolidation continues in the CRO space, with the acquisition of Chiltern by LabCorp being just the latest example of top CROs expanding and increasing their breadth of offerings. As large CROs continue to acquire smaller competitors, can sponsor companies expect to benefit from this development?

  • DIA Trends: Technology, Trial Design, & Regulators
    DIA Trends: Technology, Trial Design, & Regulators

    In his role as SVP and managing director, Americas for DIA Global, Sudip Parikh has the opportunity to look across the pharmaceutical industry at what companies are doing in regard to clinical trials. In this article, he shares his insights into what the industry can do to make trials more efficient and speed up the entire trial process.

  • Clinical News Roundup: LabCorp To Acquire Chiltern
    Clinical News Roundup: LabCorp To Acquire Chiltern

    Clinical News Roundup for the week of July 30, 2017 with information on LabCorp acquisition of Chiltern, merger of INC Research and inVentiv Health, FDA Reauthorization Act, Right-To-Try legislation, and more.

  • Use Extension Studies To Enhance Phase 3 Data
    Use Extension Studies To Enhance Phase 3 Data

    An open-label extension study is one that will lie between a double-blind, randomized controlled drug trial and FDA approval. The primary objective tends to be very different from a typical Phase 3 study, as the focus is on collecting more rigorous information on the long-term safety and tolerability of a new drug. These studies present unique challenges relating to study start-up, contracts, and selection criteria.

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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?

    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.

  • Phase I-IIA Clinical Trials Brochure

    At inVentiv Health we have the ability to expedite clinical programs and build the foundation for continued development of the product.

  • New Molecular Entities (NMEs) The Path Of Resistance

    On a global scale, the number of new molecular entities (NMEs) in development—and, more importantly, the number being approved by regulatory authorities— has dropped significantly in recent years.

  • Merge CTMS For Investigators - Enterprise Datasheet

    You want a clinical trial management system (CTMS) that is simple enough for all stakeholders to use and that delivers results.

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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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NEWS

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