FEATURED ARTICLES

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.

  • MDR-TB Study Requires A New Approach To Trials
    MDR-TB Study Requires A New Approach To Trials

    Otsuka Pharmaceutical has been an industry leader in TB drug development for over 30 years. The company is currently focused on MDR (multidrug-resistant)-TB, which refers to a form of the disease that is resistant to at least the two main first-line drugs available on the market.

    In a recent clinical trial, many of the sites lacked proper personnel, training, and equipment. Learn how the company overcame these challenges to make the trial a success.  

  • Do Your Clinical Trial Participants Feel Like Valued Customers?
    Do Your Clinical Trial Participants Feel Like Valued Customers?

    According to Roslyn F. Schneider MD, MSc, Global Patient Affairs Lead at Pfizer, patients can often have a feeling of being powerless, and be left with the impression they are there to serve the drug development process, and not the other way around. “There are times when it seems we are asking patients for their opinions simply so we can paste them in a pre-defined place in an existing system,” she says. “That is not how a company should be treating one of its most critical stakeholders. As an industry we need to continue to find new ways to incorporate participant feedback in a way that is good for patients, their families, and caregivers. This will be beneficial for our companies and societies as a whole since all of these stakeholders are very closely aligned.”

  • Can You Guess What This Trial Is Using To Fight Obesity?
    Can You Guess What This Trial Is Using To Fight Obesity?

    A promising new diet may work wonders for helping individuals lose weight and fight obesity. The trial will involve taking fecal matter from the digestive tracts of healthy and thin humans, which would then be freeze-dried and put in a pill. Individuals in the study would then ingest the pills. The research does have some validity. Researchers at the Massachusetts General Hospital in Boston have discovered the microbes in digestive tracts of healthy individuals are different from those in obese individuals.

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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.

  • Overcoming Adverse Event Challenges To Ensure Subject Safety In An Osteoarthritis Study

    A double blind, placebo controlled, parallel group, randomized study to evaluate the safety, tolerability, and efficacy of a novel, orally available small molecule for treatment of pain in osteoarthritis (OA).

  • Is Your Biobank Ready For The Challenge Of Biomarker-Based Research?

    In this whitepaper we review the key drivers impacting “traditional” biobanking and detail the challenges such biobanks face in delivering new biomarker-based research. To facilitate the discussion of approaches to overcoming these challenges, we introduce the concept of Next Generation Biobanking and define the attributes an “ideal” Next Generation Biobank would need to drive effective biomarker-based research. Finally we demonstrate the benefits of adopting a Next Generation Biobanking approach, with a case study in cancer biomarker discovery. By Mark A Collins Ph.D., BioFortis, Inc.

  • Phase II Primary Insomnia Program In Need Of Full-Service CRO Management

    Clinilabs, a contract research organization (CRO), was selected by an international drug discovery and development company to provide full-service CRO management of a phase II primary insomnia program.

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SERVICES & PRODUCTS

Biostatistical Services

Delivering high-quality and accurate data analysis, SynteractHCR is a contract research organization that provides robust and customized biostatistical services tailored to your study’s needs. At SynteractHCR, we believe that a statistician is a vital component in the clinical development process. Working as your partner, SynteractHCR’s expert biostatisticians will review your study’s needs and determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our team is trained to provide creative thinking and analysis optimized for your unique study designs. We provide access to your data in a format well-suited to your project requirements.

Strategic Resourcing Functional Services

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.

Oncology Clinical Trials

The unique patient populations, study design challenges, and special endpoints associated with oncology trials demand specialized knowledge.  INC Research/inVentiv Health's Oncology team is uniquely qualified to manage that complexity.

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.

Biostatistics Services: All Phases of Drug Development

We have proudly delivered expert statistical analyses and programming to all phases of drug development in a wide range of therapeutic areas for over 25 years.

Medical Writing

Writers with both industry and therapeutic expertise
Each member of our core regulatory and medical writing team draws on extensive industry knowledge and therapeutic expertise to effectively meet our clients’ product development requirements and provide top notch medical writing services. Each writer is a graduate-level life science scholar. They enhance their scientific and technical expertise through continuing medical education and study-specific training. Our writers also have access to internal therapeutic experts, researchers, and academics to gain sophisticated insight across many therapeutic specialties. Their experience and training enable them to expertly prepare reports in accordance with regional regulations and ICH Guidelines and to create clinical trial and regulatory documentation suitable for submission to regulatory authorities, including FDA and EMA.

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NEWS

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