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FEATURED ARTICLES

  • Lexicon Uses Patient Input To Support Primary Endpoint
    Lexicon Uses Patient Input To Support Primary Endpoint

    When Lexicon Pharmaceuticals began planning for a clinical trial on neuroendocrine tumors, there were two things it hoped to accomplish. First, it wanted to incorporate patient voice into the trial design. Second, the company wanted to incorporate some type of mobile technology into the trial to help track feedback from patients.

  • Innovative Patient Study Examines Effect Of Drug Use In Pregnant Women
    Innovative Patient Study Examines Effect Of Drug Use In Pregnant Women

    In 2009 the European Medicines Agency (EMA) launched PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium), a new research program designed to strengthen the monitoring of the benefit risk of medicines in Europe. Stella Blackburn, vice president and global head of risk management for QuintilesIMS, was heavily involved with this groundbreaking study and discusses key findings of it with Clinical Leader.

  • Clinical News Roundup: Almac And inVentiv Health Partner On IRT
    Clinical News Roundup: Almac And inVentiv Health Partner On IRT

    Clinical news roundup for the week of December 4, 2016 with information on Almac partnering with inVentiv on IRT, ERT acquiring Exco In Touch, and the 21st Century Cures bill passing the Senate and moving on to the White House.

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WHITE PAPERS AND 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.

  • What The Fitbit Is Helping Pharma Learn About Patients
    What The Fitbit Is Helping Pharma Learn About Patients

    Fitness trackers were popular holiday gifts this year and sales are on the rise. While counting steps and getting fit may be the primary reason consumers are purchasing Fitbits and other wearables, other sensors these devices include, such as heart rate and sleep monitors, could actually help big pharma collect a wealth of valuable data to revolutionize personalized medicine.

  • 10 Insider Tips For eCOA Implementation
    10 Insider Tips For eCOA Implementation

    If your organization has yet to adopt the use of eCOA (electronic clinical outcome assessments) in your clinical trials, then this white paper on successfully implementing the use of this technology should be of interest to you.

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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. 

IVRS/IWRS Services IVRS/IWRS Services

SynteractHCR offers full-featured global Interactive Voice and Web Response Systems for your clinical trial operations, through our validated 21 CRF Part 11 compliant proprietary system. Once implemented, the system is available 24/7 for use by sites, study participants and project team members. Transactions are recorded into a study-specific database, and information can be exported into custom reports. Live technical support is available to sites and study participants via phone, email or web access. SynteractHCR has successfully implemented IWRS in 30 countries and has the capability to translate 26 different languages.

Medical & Regulatory Affairs Medical & Regulatory Affairs

Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.

Medidata BalanceĀ® Medidata BalanceĀ®

Medidata Balance® is the randomization and trial supply management (RTSM) application built within the Medidata platform to unify randomization, trial supply and EDC.

  • Configurable. Range of pre-validated methodologies includes standard and innovative designs, including Boolean randomization, within a simple set-up tool allowing you to start studies faster. Methodology can be adjusted quickly and easily during live trial.
  • Integrated EDC. Integrates with Medidata EDC as a seamless RTSM/EDC system, or stand-alone RTSM system, decreasing sponsor and patient risk by eliminating disconnected systems and manual processes. Reduce development costs through rapid creation and implementation by sponsor, CRO or Medidata Services team.
  • Efficient. Clinical sites randomize, assign and track a trial drug from within the Medidata EDC system. Built-in simulator enables immediate analysis of various designs, ensuring optimal randomization.
Strategic Resourcing Functional Services 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.

Clinical Development Document Management Clinical Development Document Management

Trial Interactive is the all inclusive source for all of your clinical data management needs. In addition to hosting clinical trial solutions and electronic case site solutions, we also provide a full array of scanning and clinical document management services.

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