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?
    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
    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 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.

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  • 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 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.

  • 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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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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