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FEATURED ARTICLES

Adaptive Trials: Complex But Advantageous
Adaptive Trials: Complex But Advantageous

When I speak with pharma executives on certain topics, it’s amazing to see the difference in where companies stand in terms of implementation. Adaptive trials is one of those topics. I will talk to one executive who will tell me it is one of the trends that will most impact the pharma industry in the coming year, and then talk to another who will tell me it’s old news and something they have been doing for years. Regardless of where you stand with adoption, one thing is clear: Adaptive trials have many advantages, but are also more complex.

  • BMS’ Opdivo Trials: What They Teach Us About Successful Studies
    BMS’ Opdivo Trials: What They Teach Us About Successful Studies

    It’s hard to ignore the news around immunotherapies to treat cancer. Opdivo is a Bristol-Myers Squibb (BMS) medicine that has been approved by the FDA for patients with previously treated advanced non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. Opdivo also provides a textbook lesson for sponsor companies on how to conduct a successful clinical trial.

  • Growing To Meet The Needs Of Big Pharma: Acquisitions Help BioClinica Increase Profits by 20%
    Growing To Meet The Needs Of Big Pharma: Acquisitions Help BioClinica Increase Profits by 20%

    Recent acquisitions have convinced Mark Weinstein, CEO of BioClinica, that his company is ready to work with the largest of pharmaceutical companies, be they CRO or drug sponsor. Bio-Imaging, which officially became BioClinica in 2009 following a major merger, is currently running over 400 imaging studies with over 200 clients. Weinstein notes a series of well-planned steps were required to get them to this position.

  • Metrics Champion Consortium – Cardiopulmonary Performance Metrics Initiative

    The Metrics Champion Consortium (MCC) is a non-profit organization comprised of approximately 90 biotechnology, pharmaceutical, medical device and service provider organizations. ERT Blog with guest, Linda Sullivan – Vice President Operations, MCC

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WHITE PAPERS AND CASE STUDIES

  • Considerations When Selecting A CRO For Phase I Clinical Studies

    Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.

  • 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

  • Cardiac Safety Solutions Overview

    In the world of cardiac safety solutions, quality data is imperative. We understand your need to capture the highest qual¬ity data, on time and in the correct format.

  • Respiratory Solutions Overview

    With a non-centralized spirometry study, you can expect up to 25% unacceptable data from investigator sites, with no indication of which sites are performing poorly.

  • Clinical Outcome Assessment (eCOA) Solutions Overview

    Clinical Outcome Assessments (COAs), including Patient Reported Outcomes (PROs), Clinician Reported Outcomes (ClinROs), and Observer Reported Outcomes (ObsROs), directly or indirectly measure how patients feel or function and can be used to determine whether or not a drug has been demonstrated to provide a treatment benefit.

  • 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 AND PRODUCTS

Data Management Data Management

With more than two decades of experience providing customized data management services for clinical trials to our clients, SynteractHCR is a contract research organization that has developed a reputation for high quality, cost effective solutions to fit your unique project needs. We know the importance of accurate, timely data management for clinical trials, and that’s why we have implemented the right combination of technologies with the care and insight of experienced personnel. Our clinical data managers have medical and life science backgrounds and as well as specialized programming experience. 

Clinical Consulting Clinical Consulting

Harnessing the industry-leading expertise and unrivaled experience of its Cardiac Safety, Respiratory and Clinical Outcome Assessments scientific thought leaders, ERT’s consulting group is readily available to support you, whatever the size, complexity and therapeutic area of your clinical program.

Centralized Cardiac Safety Services Centralized Cardiac Safety Services

Proven solutions for centralized cardiac safety trial services, precise consultation and site support for global cardiac safety clinical trials.

Clinical Consulting Clinical Consulting

Harnessing the industry-leading expertise and unrivaled experience of its Cardiac Safety, Respiratory and Clinical Outcome Assessments scientific thought leaders, ERT’s consulting group is readily available to support you, whatever the size, complexity and therapeutic area of your clinical program.

Clinical Pharmacology Clinical Pharmacology

The clinical pharmacology team at ICON Development Solutions (ICON) has extensive experience in the design, study conduct and interpretation of clinical pharmacology studies across all major therapeutic areas.

First In Human Clinical Trials First In Human Clinical Trials
Timely and accurate data regarding the safety and efficacy of drug is critical for success at every stage of drug discovery and development.
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NEWS

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