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.

By combining technology and our extensive experience with investigator site selection; patient recruitment; clinical operations; data management; biostatistics, and regulatory knowledge, we’re able to improve project visibility and coordination for all stakeholders.

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.

Visibility You Can Rely On

Clinipace Worldwide trial services have been 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
  • Real-time dashboard and reporting engine
  • Data quality and query management
  • Single document repository
  • Optimize monitoring site visits
  • Milestone-driven payment
  • Adverse event reporting
  • IRB communications

With TEMPO for Clinical Trials, sponsors have immediate real-time access to critical information, including:

  • Site enrollment rates
  • Subject throughput rate
  • Data quality metrics
  • Study schedules
  • Medication dispensing
  • Milestone-driven payment
  • Adverse event reports
  • Investigator payments


The Value of Our Frictionless Methodology

Patient Accrual: With current, at-the-fingertips information on recruitment rates, resources can be directed more appropriately.

Clinical Monitoring: Just-in-time monitoring, driven by site-based data collection and activities, enhances productivity while reducing unnecessary visits.

Clean Data, Clear Decisions: Applying the right people to the proven processes and technologydriven systems, serves to minimize project risk and ensure quality.

Site Management: Automated tracking of site activities enhances its efficiency, so when contractual milestones are met, sites are paid promptly, and that makes for satisfied investigators.

Drug Supply: Combining real-time enrollment visibility with drug inventories and dispensation enables efficient timing and deployment of study drug kits and thereby reduces costs.

Study Management Simplified

As a dCRO, we built our software platform – we own it and we live it. TEMPO™ seamlessly integrates the core functional needs of any trial into a single platform. TEMPO was designed with both the investigator and sponsor in mind. Experience simple, frictionless integration with Clinipace Worldwide.

TEMPO Delivers...

  • Electronic Case Report Forms
  • Patient Reported Outcomes
  • Reporting & Workflow Engines
  • Flexible Configuration
  • Granular Permissioning System
  • Adverse Event Reporting
  • Data Validation (Clean Data)
  • Automatic Randomization
  • Monitoring Work Queue
  • Query Management
  • Milestone-Driven Site Payment
  • Inventory Management
  • Audit Trail & eSignature
  • 21 CFR Part 11 Compliant
  • CDISC ODM Support

Clinipace Worldwide 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

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