FEATURED ARTICLES

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.

  • Clinical News Roundup: Is 80 Percent Of China’s Clinical Data Fabricated?
    Clinical News Roundup: Is 80 Percent Of China’s Clinical Data Fabricated?

    Radio Free Asia (RFA) is reporting that a government investigation in China has revealed fraudulent practice on a massive scale in clinical trials. China's food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is "fabricated," state media reported.

  • Podcast: Pfizer Transforms Clinical Trials for Parkinson’s Patients
    Podcast: Pfizer Transforms Clinical Trials for Parkinson’s Patients

    When Pfizer partnered with IBM to try and transform how clinical trials for Parkinson’s patients are conducted, the company had a vision that was both revolutionary and futuristic. The plan was to take a group of patients, place them in a specially designed home to live for a period of time, and use sensor technology to monitor their capabilities.

  • SCDM Best Practices Now Available To Nonmembers
    SCDM Best Practices Now Available To Nonmembers

    Data managers are critical to the clinical research process. It’s the data they collect which will ultimately determine whether a new drug gains FDA approval. Recognizing that, the Society for Clinical Data Management (SCDM) was established to work with the teams creating clinical trials, writing the protocols, and identifying the information that needs to be captured. Over the years, the information gathered by SCDM members has been incorporated into a guide book of Good Clinical Data Management Practices, which SCDM is now making available to nonmembers as well as association members.

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WHITE PAPERS & CASE STUDIES

  • Synergy Chooses ClinCapture

    In 2007 Synergy opened a Clinical Data Management Department with local, low-budget projects and decided to implement an open source EDC solution as a clinical data collection tool. This tool required installation and validation every time a new project was started. When the number of projects started to multiply, management quickly realized they had two options: expand their IT resources to support data management applications or outsource. They chose the second option so they had to find a cost-effective, pay-as-you-go, cloudbased EDC solution which would allow them to move their current EDC projects without interruption.

  • Transforming Clinical Business Wth An Enterprise Approach To EDC

    In 2005, Abbott sanctioned an executive-sponsored governance body to drive the development and implementation of enterprise-wide study build, data capture and trial management processes using a single electronic data capture (EDC) vendor for all clinical studies. The objective was to quickly move the lion’s share of studies to electronic capture means while maximizing site acceptance.

  • How Your Electronic Data Capture (EDC) System Can Streamline Clinical Site Payments

    Today, EDC systems are widely adopted by life science companies and well established as a critical technology for conducting clinical research, especially for large multi-site trials.

  • Combining The Discipline Of Clinical R&D With The Promise Of mHealth

    Mobile health (mHealth) technology will redefine how we conduct clinical R&D. Consumer-friendly technologies, including remote sensors, wearable devices and mobile apps, offer clinical development access to potentially rich, sensitive patient data that not only complements existing sources—providing a more complete view of therapy safety and efficacy—but may also provide a better understanding of disease.

  • Medidata Patient Cloud: A New Model For Patient-Reported Outcomes

    Why in this day and age, with people connected 24x7 via smartphones and apps, do clinical trials still use paper to capture patient-reported outcomes (PROs)? ePRO solutions have been around for decades, but up to half of studies still use paper to capture patient assessments.

  • Beyond EDC: Speeding Treatments To Patients With A Unified Clinical Technology Platform

    As clinical trials represent a substantial portion of R&D costs, the adoption of electronic data capture (EDC) over the last 15 years has contributed to these efficiencies. However, forward-thinking life sciences companies increasingly recognize that replacing paper with EDC is not an end in itself.

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SERVICES & PRODUCTS

Clinical Operations Clinical Operations

Clinical operations are a critical component in all studies. SynteractHCR’s highly skilled staff is well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study. From start-up to close-out, experienced clinical managers and clinical research associates (CRAs) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.

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. 

Biostatistical Services Biostatistical Services

Delivering high-quality and accurate data analysis, SynteractHCR is a contract research organization that provides robust and customized biostatistical services tailored to your study’s needs. At SynteractHCR, we believe that a statistician is a vital component in the clinical development process. Working as your partner, SynteractHCR’s expert biostatisticians will review your study’s needs and determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our team is trained to provide creative thinking and analysis optimized for your unique study designs. We provide access to your data in a format well-suited to your project requirements.

Medidata Rave® Medidata Rave®

Leading and specialty CROs across the industry use Rave with their clients. Medidata's industry-leading Services Partner program helps CROs bring the best technology to their clinical development activities.

Rave is:

  • Flexible. Don’t twist your processes to fit technology limitations.  Rave flexibility accommodates your workflow requirements.  Make mid-study changes—including adaptive trials, protocol amendments and updated requirements—easily with no system downtime. Rave manages multiple case report form (CRF) editions and seamlessly migrates existing data into new forms and structures.
  • Scalable. Rave’s cloud-native architecture scales from one study to hundreds, and from Phase-I all the way to global Phase-IV. Whatever your trial phase or business growth, one cloud system is all you need.
  • Configurable. Simple or complex study requirements, Rave handles them all without custom programming. Easily configure CRFs, workflows, data blinding, source document verification (SDV) requirements, dictionary coding and more. All via a point-and-click browser interface.

(Please scroll down to access white papers, case studies and data sheets.)

eHealth Cloud: Clinical Trial Platform eHealth Cloud: Clinical Trial Platform

The BioClinica eHealth Cloud is a flexible and highly configurable platform offering that extends beyond the scope of traditional clinical trial technology approaches.

Express EDC (Electronic Data Capture) Express EDC (Electronic Data Capture)

Why is Express EDC used by Sponsors and CROs to build studies and capture data for thousands of clinical studies worldwide? To sum it up: You get more. Do more. See deeper into your studies and manage study data, not just capture it — all within a single, powerful solution that puts everything at your fingertips. Ideal for any clinical trial regardless of size, phase or complexity, Express is the foundation of many leading research programs and is used on thousands of studies worldwide.

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NEWS

  • Medidata Collaborates With GlaxoSmithKline On Mobile Health Initiative To Test Novel Technology For Clinical Trial Optimization

    Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the completion of a method development project conducted in partnership with GlaxoSmithKline plc (GSK) to evaluate the impact of unifying mobile health (mHealth) devices with cloud-based technologies in a clinical trial setting. The joint initiative assessed the capabilities of mHealth tools and evaluated how they could be used to enable a new model for clinical trial conduct that aligns site and patient needs with faster study execution and reduced costs.

  • Medidata And PPD Partner To Offer New Approach To Risk-Based Monitoring

    Medidata (NASDAQ: MDSO), a leading global provider of cloud-based solutions for clinical research in life sciences, and Pharmaceutical Product Development, LLC (PPD), a global contract research organization (CRO), today announced they are expanding their partnership to provide the life science industry with a more comprehensive approach to risk-based
    monitoring (RBM)—aimed at conducting drug development more intelligently, more quickly and more cost-effectively.

  • Comprehend Raises $21 Million In Series B Funding

    Comprehend today announced it has secured $21 million in Series B financing to accelerate clinical development through its cloud-based business intelligence solutions, enabling life science companies to bring new treatments and devices to market faster and more affordably. The round was led by Lightspeed Venture Partners with support from existing investor Sequoia Capital. Lightspeed partner Peter Nieh joined the company’s board of directors.

  • Medidata And TransCelerate BioPharma Inc. Announce Joint Initiative

    Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that it is partnering with TransCelerate BioPharma Inc. ("TransCelerate") on a project designed to inform the nonprofit organization’s continued efforts to modernize and streamline the way clinical trials are conducted and monitored worldwide.

  • Laurence Burke Joins Exco Intouch As Vice President Of Operations

    Exco InTouch, the leading provider of patient engagement and data capture solutions for clinical research and healthcare providers, recently announced the appointment of Laurence Burke as Vice President of Operations.

  • NextDocs Receives $13.5M In Funding To Fuel Expansion

    NextDocs, a leading provider of regulated content management and compliance solutions, announced recently that the company has received a $13.5M round of investments and funding commitments.  The funding round was led by OpenView Venture Partners with participation by Eastward Capital and Bridgebank Capital

  • Spanish Biotech PharmaMar Selects Medidata Clinical Cloud To Accelerate Trials For Marine-Based Oncology Drugs

    PharmaMar, a Spanish biopharmaceutical company, has selected Medidata Solutions (NASDAQ: MDSO) for its industry-leading electronic data capture (EDC) and clinical data management (CDM), safety data capture and reporting, and medical coding solutions. A member of the Zeltia Group and a leader in the development of antitumor drugs of marine origin, PharmaMar said the company’s investment in the Medidata Clinical Cloud™ will efficiently streamline its clinical trial processes in its mission to deliver drugs that treat cancer and rare ("orphan") diseases.

  • Northwise Services Partners With Merge To Offer Comprehensive Clinical Trial Services

    Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that NorthWise Services (NWS) has partnered with Merge and selected eClinical OS™ to collect, manage and report on clinical trials data across all studies.

  • Exco InTouch Joins Critical Path Institute ePRO Consortium To Advance Electronic Data Capture In Clinical Trials

    Exco InTouch, the leading provider of patient engagement, data collection and communication solutions for the pharmaceutical and healthcare sectors, recently announced that it has joined the Electronic Patient-Reported Outcome (ePRO) Consortium, a programme run by the Critical Path Institute (C-Path), which strives to enhance the quality of patient reported outcomes (PRO) in the evaluation of new pharmaceuticals.

  • Stiris Research And Statistics & Data Corp. Form Strategic Partnership

    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.  

  • Clinovo Releases The New Version Of ClinCapture, The Most Feature-Rich Open-Source EDC

    Clinovo will release for the first time at the annual Outsourcing in Clinical Trial West Coast conference (booth #43), the new version of ClinCapture, its open-source Electronic Data Capture (EDC) system.

  • NCGS Incorporated Selects Merge eClinical OS™ For Phase I-IV Studies

    Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that NCGS Incorporated has selected Merge’s eClinical OS™ and clinical trial management (CTMS) solution to streamline data management activity through electronic data capture (EDC) technology transfer and improve study management efficiency.

  • Datapharm Australia Selects Merge eClinical OS™ For Enterprise-Wide Electronic Data Capture

    Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that Datapharm Australia Pty Ltd. has selected Merge’s eClinical OS™ solution to bring EDC in-house and provide control of electronic case report form (eCRF) creation and mid-study adjustments.

  • Bellicum Selects DATATRAK Solution For Drug Program

    DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the award of a multi-million dollar, five-year technology and services agreement with Bellicum Pharmaceuticals.

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