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

  • 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.

  • Regulatory Approval Of Clinical Studies In The Netherlands

    The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands. 

  • 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.

  • eTMF And The eClinical Universe

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

  • Streamline And Accelerate A Drug Development Plan Using The 505(b)(2) Pathway

    An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. Product X is a prodrug that is converted in one metabolism-dependent step to produce the active metabolite of an approved drug.

  • Signature Requirements For The eTMF

    Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.

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SERVICES & PRODUCTS

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.

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.

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.

Clinical Trial Feasibility

Delays in research have significant time and cost implications and negatively impact an organization, regardless of size or financial stability. The potential for delays can be decreased or mitigated through comprehensive planning.

Oncology Services
A leading western CRO in Russia, ClinStar offers invaluable experience to enhance your study execution, resulting in higher-quality results. We offer local regulatory, customs and logistical expertise, as well as clinical teams that are therapeutically trained in oncology.
CNS Services

A leading western CRO in Russia, ClinStar offers invaluable experience to enhance your study execution, resulting in higher-quality results. We offer local regulatory, customs and logistical expertise as well as clinical teams that are therapeutically trained in CNS diseases.

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NEWS

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