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

Study Start-up: Information from pre-study visits are communicated more quickly, site initiation activities and regulatory documents are universally shared and better managed; leading to reduced cycle times and faster site activations.

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.

Site Management: Automated tracking of site activities enhance the efficiency so when contractual milestones are met, sites are paid promptly, making for satisfied investigators.

Drug/Device 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 Close-out: Consistent remote and just-in-time monitoring enables timely resolution of data discrepancies (even preventing problems), ensuring higher-quality data and faster database lock; allowing analysis and site close-out visits to occur much earlier than with traditional processes.

Metrics You Can Rely On

The transparency that underlie our methods serves to instill confidence in clinical trial operations. In accessing the trial meta-data, stakeholders can see how standard operating procedures (SOPs) are/were operationalized in the trial. The integration of clinical and meta-data within a single system delivers a more comprehensive picture of the overall conduct of the trial. The use of technology thus enhances quality control and project efficiency; but also makes the evidence of these artifacts easily manifest through the use of performance metrics, such as:

Site Activation

  • Cycle time to site qualification
  • Cycle time to first site activated
  • Cycle time to site activated
  • Regulatory pack approval rate
  • Percent planned sites activated

Site Performance

  • Cycle time from activation to FPFV
  • Site productivity (% meeting goals)
  • Screen failure rate
  • Patient accrual
  • Patient drop out rate

Data Quality

  • Cycle time to CRF data entry
  • Data discrepancies
  • Query response time
  • Source data verification

Close Out

  • Cycle time for query resolution
  • Cycle time from LPLV to data lock
  • Cycle time to site close out
  • Issue identification & resolution


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