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.
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.
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.”
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.
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.
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).
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.
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.
One common theme in the pharmaceutical, biotechnology and medical device industry is the constant pressure to accelerate development of drugs, biologics and products to market. By Bill Gluck, PhD, DATATRAK, and Lorraine D. Ellis, MS, MBA, Research Dynamics Consulting Group, Ltd.
MMS Holdings Inc. recently announced that it has successfully executed disclosure management services for several clients and is poised to make strides in this area with its proprietary software, TrialAssure.
Quanticate, one of the worlds leading data-focused CROs specializing in the provision of biostatistics, programming, data management, medical writing and pharmacovigilance services has been named category winner for Innovation in the 2013 CRO Leadership Awards presented by Life Science Leader magazine.
CRF Health, the developer of the TrialMax® Suite of electronic Clinical Outcome Assessment Solutions (eCOA) for the life sciences industry, becomes the first eCOA company to complete a full validation study for Professor Juniper’s ACQ and AQLQ questionnaires to the “Gold Standard” based on her recently released “Levels of Acceptability of Electronic Versions” rating system.
Stiris Research has entered into a strategic partnership with Statistics & Data Corporation (SDC) to offer seamless implementation of full-service Clinical + Biostatistics and Data Management/EDC solutions.
WuXi PharmaTech, a leading contract research organization with operations in China and the United States, and PRA, a leading global clinical contract research organization, recently announced that they have signed a joint venture agreement to offer a broad platform of Phase I-IV clinical trial services in China, Hong Kong and Macau.
Chief executive officer Dr. Emma Banks of Datatrial, a boutique clinical data organization, has accepted an invitation to join the Strategic Advisory Board of Bionow, a life science membership organization focused on the North of England.
Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, today announced that Tigermed Consulting Co., Ltd. has selected Merge eClinical's CTMS solution for Sponsors and CROs to streamline clinical trial management (CTMS) and maximize operational efficiency across its studies.
Darlene Panzitta, President and Founder of DSP Clinical, is among this year's PharmaVOICE 100 List of the most influential people in lifes sciences industries.
Synteract, Inc., a full-service contract research organization (CRO), will host the roundtable, “Beyond number-crunching and data-monitoring: challenging roles for CRO statisticians,” at the Joint Statistical Meetings (JSM), on August 1, 2012 at 12:30 p.m., PDT. The roundtable will be moderated by Jia Hu, biostatistician II, from Synteract. JSM is the largest gathering of statisticians held in North America, attended by more than 6,000 people.
Lophius Biosciences, a leading developer of novel T-cell based diagnostic testing systems, today announces the successful completion of a prospective multicenter clinical validation study for its T-Track® CMV/EBV tests
This quarter, DataCeutics, Inc. generously donated an iPad and a mobile iPad stand for patients in the Lehigh Valley Hospital Burn Center. Liz Dideon Hess, the Social Worker who provides emotional support to patients and family members coping with burn injuries said, “To call it a wild success would be quite an understatement!”