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FEATURED ARTICLES

  • 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.

  • What You Need To Know About FDA’s Clinical Outcome Assessment Compendium
    What You Need To Know About FDA’s Clinical Outcome Assessment Compendium

    One of the goals of CDER (The FDA’s Center for Drug Evaluation and Research) is to foster patient-focused drug development. As part of that effort, the agency has published a compendium of clinical outcome assessments (COAs) to promote the use of patient-focused outcome measurement in the drug development process.

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WHITE PAPERS AND CASE STUDIES

  • Healthcare Company Expects Online Collaboration To Save Millions Of Euros
    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
    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    According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such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
    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.

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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.

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.

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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