FEATURED ARTICLES

Pharma “Not Prepared” For New EU Data Protection Regulation
Pharma “Not Prepared” For New EU Data Protection Regulation

Pharmaceutical companies, CROs, and software/application vendors with operations in the European Union (EU) may be at serious risk from the new EU General Data Protection Regulation (GDPR). Violations of the regulation, which is set to go into effect in 2018, can result in penalties of €20 million or 4 percent of worldwide revenue.

  • Clinical News Roundup: Why All The Love For Adaptive Trials?
    Clinical News Roundup: Why All The Love For Adaptive Trials?

    Clinical News Roundup for the week of April 10, 2017 with information on Scott Gottlieb and adaptive approaches, preparing for epidemic clinical trials, proposed tax law changes for clinical research, and using selfies to improve medicine adherence.  

  • Clinical News Roundup: RBM Leads To Cost Savings
    Clinical News Roundup: RBM Leads To Cost Savings

    Clinical news roundup for the week of April 1, 2017 with information on RBM and cost savings, a culture change around clinical data, proposed clinical research tax credits, increasing patient diversity, the pharma industry in Mexico, and patient trust and satisfaction.

  • The Science Of M&A: Making The Most Of Your Financial Resources
    The Science Of M&A: Making The Most Of Your Financial Resources

    As CEO for France-based biotech Onxeo, CEO Judith Greciet is always looking for new opportunities to bring complementary products on board to expand her company’s pipeline. Onxeo currently has three compounds in clinical development, with one at the end of its Phase 3 trial. “External development is a key path in our strategy to grow the company,” says Greciet. “Whether you refer to this as an acquisition or inlicensing, we knew we would require additional, innovative assets to widen our pipeline and increase the value of the company.”

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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.

  • 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

    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.

  • Poor Protocol Design Is Costing You More Than Money

    Several recent analyses have called attention to the increased scientific and operational complexity of today’s clinical trials.

  • When Your Timeline Is Cut Short On A Global Data Management Project

    PRA Health Sciences performed data management activities for this project while the client was responsible for all other services, including site monitoring. When the client reduced the timelines for database lock by approximately 9 months, PRA immediately created a detailed closure plan, listing all tasks and activities that required completion within the given timelines. This plan was reviewed and approved by all parties involved. To successfully complete the closeout period, PRA calculated data flows and trained additional staff members.

  • See Up To 65% Time Savings With eSource Data Collection Methodology

    As technology solutions are increasing in adoption in the clinical research industry, ways to maximize their efficiencies are being more closely considered. eSource is emerging as a possible process to remove complexities and deliver time and cost savings to studies. By Niki Kutac, Director, Product Management, DATATRAK

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SERVICES & 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 Balance® Medidata Balance®

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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NEWS

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