CLINICAL DATA MANAGEMENT WHITE PAPER & ARTICLES

  • User Acceptance Testing And RTSM System Validation
    User Acceptance Testing And RTSM System Validation

    When implementing a randomization and trial supply management (RTSM) system for a clinical trial, there is a shared responsibility between the RTSM vendor and sponsor organizations to ensure the system performs as intended according to predefined requirements. 

  • Modern Technologies In Clinical Trials
    Modern Technologies In Clinical Trials

    Trial designs are becoming more complex. Most of these trials are supported by legacy/older technologies that have limited flexibility to quickly adapt to new trial information. The pharmaceutical industry is reaching a tipping point, where the need for flexibility is outweighing the need to be conservative and risk-averse in this highly-regulated environment.

  • Understanding The New ICH-GCP Landscape
    Understanding The New ICH-GCP Landscape

    Can organizations implement today’s regulatory requirements using conventional approaches?

  • Integrating mHealth - Transform Medical Product Pipelines And The Patient Care Continuum
    Integrating mHealth - Transform Medical Product Pipelines And The Patient Care Continuum

    Examine how mHealth will drive clinical development, support more effective models of integrated care delivery and the technical issues that can arise.

  • King Arthur’s Excalibur in ICH E6 (r2)
    King Arthur’s Excalibur in ICH E6 (r2)

    What is the medical monitor's role in the latest ICH E6 (r2) guidance and how to get them to adopt technology that will help them experience tangible efficiency and quality gains.

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CLINICAL DATA MANAGEMENT APPLICATIONS & STUDIES

  • The Stakes Were High In This Phase II Study, But The Risk Was Under Control

    Software solutions provider adds value for a midsize pharmaceutical company from a quality, cost and study governance perspective by enabling them to implement risk-based (dynamic) approaches to monitoring.

  • SENA Incorporates Participant Payment Automation To Improve Clinical Trial Operations

    Southeastern Nephrology Associates (SENA) have been providing high quality nephrology, kidney dialysis, kidney transplant and hypertension care for patients since 1975.

  • Transforming Clinical Development

    To enable the completion of clinical trials as safely, efficiently and quickly as possible, PerkinElmer Informatics’ clinical solutions streamline clinical trial data visualization and analysis with real-time access to clinical data in all phases of clinical development.

  • Achieving Clinical Operations Excellence

    Learn how PerkinElmer’s clinical solutions give clinical operations organizations the unprecedented ability to reduce the time, cost and risk of running clinical trials while accelerating the time to market for products across the entire portfolio of clinical candidates.

  • Solutions For The Strategic Assessment Of Clinical Data In Trial Operations

    Achieve clinical trial operations excellence using this an innovative solution that gives clinical operations organizations the unprecedented ability to reduce the time, cost, and risk of running clinical trials while accelerating time to market for products across the entire portfolio of clinical candidates.

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CLINICAL DATA MANAGEMENT PRODUCTS & SERVICES

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.

TrialMax Web™ eCOA (Electronic Clinical Outcomes Assessments) TrialMax Web™ eCOA (Electronic Clinical Outcomes Assessments)

TrialMax Web™ is a web-based diary specifically designed for late phase trials, which tend to be larger and longer in duration.

TrialMax Touch™: eCOA Handheld Diary TrialMax Touch™: eCOA Handheld Diary

TrialMax Touch™ is a handheld diary that can be used by patients at home or by the caregiver. TrialMax is a software platform that provides a single solution for eCOA (electronic Clinical Outcome Assessments) in Phase I to IV clinical trials.

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.

eCOA Data Management Services eCOA Data Management Services

Our dedicated, centralized eCOA (eletronic Clinical Outsome Assessments) Data Management group acts as an extension to your own team.

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.

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. 

Medical Device Integration With eCOA Solution Medical Device Integration With eCOA Solution

Studies where patients use a medical device at home provide a great opportunity for leveraging the eCOA solution in automating data collection from the medical device. 

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