Clinical Trials

Operationalize Your Protocol

Whether you’re engaged in a single site, 25 patient phase I study, an adaptive phase I/II trial, large global phase III with dozens of sites and thousands of patients, or a phase IV safety study, Clinipace Worldwide can help you affordably operationalize your protocol and gain visibility into your clinical development program or individual project.

Optimized by technology, we deliver research services such as project management, monitoring, site management, data management (EDC-based), supply management, and biostatistics at up to 30% savings compared to traditional service providers.

Additionally, the Clinipace Worldwide team offers trial and registry services related to site selection and patient recruitment, medical monitoring, medical writing, IRB administration, safety surveillance, and regulatory guidance.

The power and flexibility of the Clinipace Worldwide approach allows all project stakeholders to access user-appropriate trial information whether they are in the office, working from home, or traveling to a study site.

Examples of how sponsors utilize Clinipace Worldwide for Clinical Trials:

Solutions Sponsor A Sponsor B Sponsor C Sponsor D
TEMPO™
Data Management
Monitoring
Site Management
Biostatistics
Medical Management


Commitment to Clean Data and Clear Decisions

It is critical to ensure a good experience for the investigator while meeting study objectives for the sponsor. Our trial management and data capture technology was designed with both the investigator and sponsor in mind, providing investigator sites with the ability to focus on science and medicine and providing sponsors with the ability to access real-time trial information to make important decisions throughout the life of the trial:

  • Simple and quick data collection
  • Protocol compliance
  • Data quality and query management
  • Real-time reporting engine
  • Milestone-driven payment
  • Optimize site visits
  • Increased accuracy
  • Adverse event reporting
  • IRB communications

With Clinipace Worldwide, sponsors have immediate real-time access to critical information, including:

  • Site enrollment rate
  • Subject throughput rate
  • Data quality metrics
  • Study schedules
  • Medication dispensing
  • Adverse event reports
  • Investigator payments

Right-Sized™ Clinical Trial Services

Clinipace Worldwide balances the needs of sponsors and investigators by providing the complete technology and service infrastructure to collect, monitor, and manage study data and associated clinical operations.

Clinipace Worldwide technology (EDC/ePRO) provides:

  • Complete visibility into all aspects of your trial
  • Study set-up and support
  • Simple eCRF creation, data collection and trial management tools
  • Powerful reporting engine
  • Robust data validation and management
  • Query and monitoring management
  • Workflow management
  • Audit trail
  • eSignature

Clinipace Worldwide Service Delivers...

Project Management

  • Technology set-up & implementation
  • Good Clinical Practice Adherence
  • Comprehensive project plan
  • Site coordination
  • Project lifecycle management
  • EDC best practices
  • Training

Monitoring

  • Ensure informed consent
  • Complete site management
  • Ensure protocol compliance
  • Review study files for completeness
  • Query resolution
  • Source data verification
  • eCRF review
  • Identify AE/SAE
  • Drug accountability

Data Management

  • Data validation and cleansing
  • Quality assurance
  • Manage audit database
  • Medical/Clinical coding
  • Project-specific data dictionaries
  • Third-party data reconciliation
  • Biostat preparation

Biostatistical Services

  • Statistical support for study design
  • Consult on randomization methodology
  • Detailed statistical analysis
  • Real-time reporting
  • Documentation
  • Production of tables, listing & figures
  • Support for manuscripts & abstracts