FEATURED ARTICLES

Adaptive_Trials Use Extension Studies To Enhance Phase 3 Data

An open-label extension study is one that will lie between a double-blind, randomized controlled drug trial and FDA approval. The primary objective tends to be very different from a typical Phase 3 study, as the focus is on collecting more rigorous information on the long-term safety and tolerability of a new drug. These studies present unique challenges relating to study start-up, contracts, and selection criteria.

  • clinical news
    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.”

  • Patient Survey: Technology Use Up, Pharma Disconnect Remains
    Patient Survey: Technology Use Up, Pharma Disconnect Remains

    The patient advocacy firm Inspire has released the results of its second annual Insights From Engaged Patients survey. Over the last two years, Inspire has captured insights from nearly 24,000 patients and caregivers who face multiple health conditions. The survey looked into several areas related to patient interactions with social media, physicians, and most importantly, pharma companies.

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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.

  • 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.

  • Electronic Drug Accountability Sytems In Clinical Trials

    Ensure drug compliance, safety and data integrity in clinical trials with electronic drug accountability systems.

  • Electronic Informed Consent: Considerations For Implementation In Clinical Trials

    In an era where data acquisition (eg. ePRO), capture (EDC) and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process.

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SERVICES & PRODUCTS

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

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

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.

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.

ClinicalDevelopmentDocumentManagement
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.

16th Annual eClinical Technologies Summit

Designed for Clinical Informatics, Clinical Data Management, EDC & CTMS

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NEWS

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