FEATURED ARTICLES

6 Strategies To Stretch Your Limited Drug Supply for Clinical Studies
6 Strategies To Stretch Your Limited Drug Supply for Clinical Studies

These clinical packaging strategies can be used to help successfully manage the supply of an expensive drug product throughout the duration of clinical testing. Without doing so, there could be costly interruptions or extended delays that would have a devastating impact on a company’s timeline to commercialization.

  • 4 Villains That Can Delay Your Clinical Trial Agreement (CTA) And How To Defeat Them
    4 Villains That Can Delay Your Clinical Trial Agreement (CTA) And How To Defeat Them

    Imagine for a moment you are your favorite superhero, charged with the task of saving the whole world from villains such as the Joker, Lex Luthor, Doctor Doom, and the Green Goblin. You would not be very effective — or much of a superhero, for that matter — if you only took one of them out while letting the others roam free. In the same way, as an industry, we cannot effectively tackle the issue of delays in the execution of Clinical Trial Agreements (CTAs) by only addressing one or two of the “villains” contributing to this industrywide problem. 

  • The 4 Biggest Investigator Site Payment Issues — And How To Solve Them
    The 4 Biggest Investigator Site Payment Issues — And How To Solve Them

    Imagine that after a tedious job interview process you are finally offered what promises to be a fulfilling and rewarding position with a new company. However, after working there for a while, you notice that the employer is only really paying you every three to six months, which has made it difficult to keep up with your bills and to stay financially afloat. You also notice that when you do receive a check from the employer, you have no way of verifying for which days or hours you have been paid since no explanation is sent with the check and you were never told who at the company you could contact for these types of questions.

  • Biopharma Trends That Will Impact The Industry In 2016
    Biopharma Trends That Will Impact The Industry In 2016

    The beginning of the year is always a good time to take a look ahead at the trends most likely to impact the industry in the coming months. One area that is changing quickly, and which promises to impact clinical trials in the coming years, is biopharma. I recently spoke with Jim Esinhart, CEO of Chiltern, about some of these trends, including study protocols, big data, mergers, and new technologies.

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WHITE PAPERS& CASE STUDIES

  • Healthcare Company Expects Online Collaboration To Save Millions Of Euros

    Sanofi is a multinational pharmaceutical company engaged in the research and development, manufacturing, and marketing of prescription drugs, vaccines, and over-the-counter healthcare products.

  • Recruiting Patients With Impaired Renal Function Case Study

    According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such patients and when renal impairment is likely to mechanistically alter the PK of the drug and/or its active metabolites.

  • Phase II Alzheimer's Case Study

    A double-blind, Phase II, placebo-controlled clinical trial to evaluate the safety and efficacy of a novel compound in subjects with mild to moderate Alzheimer’s disease.

  • Eight Best Practices For Compliant Essential Site Regulatory Documents

    In the push to initiate clinical trials, activating sites is understandably the primary focus—leaving essential site regulatory documents as a secondary priority and a bit of a “necessary evil.” Indeed, most sponsors and CROs approach essential site regulatory documents as a check-the-box exercise. By Patrice Pompa, Director, Regulatory Document Management Services and Kevin T. Williams, MBA, MS, Vice President, Corporate Development and Marketing, CFS Clinical

  • Advances In Electronic Data Capture Of Medical Data

    Electronic Data Capture (EDC) refers to the collection of medical data for patients enrolled in clinical trials. The most common mechanism is for staff at the investigative site to enter the data into a web-based interface, and for staff at the sponsor company to monitor the data using the same interface but with different security permissions. By Keith Howells

  • Moving Towards An Electronic Environment In Clinical Trials

    With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.

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SERVICES & 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.

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

With decades of experience in clinical trial design, INC Research/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.

Functional Outsourcing Functional Outsourcing

As a Clinical Outsourcing provider, RDP Clinical offers a scalable resourcing model that provides a comprehensive Clinical Site Management and Monitoring function across multiple projects, therapeutic areas or entire clinical programs. 

Late Phase Research Late Phase Research

Whether it is comparative effectiveness, outcomes or increasing market penetration, our Late Phase and Outcomes Research Group capitalizes on the expertise of our dedicated Phase IIIb/IV project operations group coupled with our extensive experience in scientific services and outcomes research.  

Product Lifecycle Consultancy Services Product Lifecycle Consultancy Services

ICON’s Lifecycle Sciences group offers the full range of services to assist clients with activities throughout the product lifecycle.

Panther-Clinical Trial Mgmt System (CTMS) Panther-Clinical Trial Mgmt System (CTMS)
Panther CTMS is an end-to-end clinical trial management system that unifies the organization of data, document, and processes.
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NEWS

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