CLINICAL DATA MANAGEMENT WHITE PAPER & ARTICLES

More White Paper & Articles

CLINICAL DATA MANAGEMENT APPLICATIONS & STUDIES

  • 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.

  • eCOA Supports Successful Antianginal Trial

    Gilead Sciences’ previous studies of Ranexa (ranolazine) relied on data from exercise treadmill parameters as the primary endpoint. But collecting data in this manner is costly, logistically challenging, and bears questionable clinical relevance — especially at the individual patient level. Learn how Gilead Sciences successfully utilized ERT handhelds to collect regulatory-compliant, patient-driven data in support of the primary efficacy endpoint in a Phase IV study of Ranexa.

  • Electronic Columbia Suicide Severity Rating Scale Included In A Wider Range Of Clinical Studies

    The objective of this study was to compare the equivalence of a new version of the electronic Columbia-Suicide Severity Rating Scale that was administered on a tablet device. The results supported the validity and reliability of the new tablet-based electronic Columbia-Suicide Severity Rating Scale and allow its inclusion in a wider range of clinical studies, particularly where a tablet is also being used to collect other study data.

More Applications & Studies

CLINICAL DATA MANAGEMENT PRODUCTS & SERVICES

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.

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.

Clinical Data Collection Network Services Clinical Data Collection Network Services

We identify the best data collection networks for each locale and patient population to ensure even your most complex clinical study is globally optimized and runs trouble free.

Prancer Randomization & Trial Supply Management Prancer Randomization & Trial Supply Management

RANDOMIZATION
Our team has extensive experience developing complex randomization schemes, including dynamic allocation (adaptive randomization).

Prancer supports central randomization, site blocked randomization, multiple strata, dynamically blocked to strata, dynamically blocked to strata and site as well as multiple randomizations.

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.

eCOA Collaborative Design Services eCOA Collaborative Design Services

Our collaborative design process and TrialMax® technology allows us to work closely with study teams from the start. This allows us to develop the very best and easy-to-use eCOA design for your clinical trial rapidly and cost-effectively.

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.

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. 

More Products & Services