FEATURED ARTICLES

The Unexpected Challenges Of Moving From Discovery To Clinical The Unexpected Challenges Of Moving From Discovery To Clinical

Keystone Nano, a small oncology-focused company in State College, PA, recently received an IND approval from the FDA and launched its first clinical trial. While that transition from discovery to clinical is an exciting time for most companies, it is also a time of greater challenges as your product is used in humans for the first time. Jeff Davidson, CEO of Keystone Nano, has learned about many of these challenges first-hand.

  • Can We Improve On ClinicalTrials.gov?

    Today, patients and pharma professionals looking for information on clinical trials generally visit ClinicalTrials.gov. On the site, users can search by condition/disease, country, and other keywords. Patients can find studies in which to participate, and researchers are able to find information on more than 250,000 studies being conducted in the U.S. and 200 other countries. But is it time for a new database that better meets the needs of pharma executives and researchers?

  • Become The Clinical Partner Of Choice

    Many pharmaceutical companies have started to look at their processes through the lens of valued, external partners. While companies will continue to evaluate the effectiveness of their external partners, many are increasingly looking in the mirror to see at what kind of partner they are to work with.

  • Distrust Of Trials Declining Among Minority Populations

    Distrust of pharma companies and clinical trials has long been cited as one reason for the low enrollment numbers of minorities in clinical studies. But a new survey finds that lack of trust may be waning, while other factors continue to contribute to low participation rates.

WHITE PAPERS & 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.

  • 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 INC Research/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.

  • Improving Life Science Operations With Digital Signatures eBook

    Today, 8 of the top 10 pharmas and 6 of the top 10 CROs use ARX’s CoSign® digital signature solution to help them benefit from fully electronic regulatory document lifecycles, compliance with various FDA GxP regulations, and efficiency in supporting audits.

  • eTMF And The eClinical Universe

    How Electronic Trial Master Files (eTMFs) Work With Other eClinical Systems To Help You Meet Regulatory Requirements.

SERVICES & PRODUCTS

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.

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.

Strong site relationships and efficient study start-up
Successful study execution requires more than just source data verification (SDV) and on-site clinical monitoring. Our clinical operations team ensures efficient study start-up, quick enrollment, and high quality execution at the site-level through extensive therapeutic and regulatory knowledge, solid training programs, and development of strong site relationships. Our clinical operations experts also have extensive experience designing and executing decentralized and virtual clinical trials.

Due to the complexity of clinical trials and the constant struggle to keep trials on schedule, Rho is often called on to resolve issues when processes don't go as planned.

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