Clinical Operations

Program / Project Management

At PROMETRIKA we work closely with our pharmaceutical, medical device and biologics clients to oversee all aspects and phases of their clinical development programs.  Our comprehensive Project Management services support timely program/trial initiation and successful trial conduct.  Program/Project Managers lead the following activities:

Study Management

  • Clinical Study Feasibility Assessment
  • Investigator Contract Negotiations
  • Program/Study Timeline Management
  • Communication Plan Management
  • Risk Management
  • Vendor Selection and Management
  • Subject Accrual and Retention Strategies
  • Enrollment Projections and Management

Success throughout the course of a trial or program is enhanced by monitoring of various study metrics.  PROMETRIKA’s Program and Project Managers routinely review and utilize the following:

Ongoing Study Metrics

  • Enrollment
  • Monitoring Expectations
  • Data Management
  • Budget Monitoring
  • Performance Monitoring

Clinical Monitoring

PROMETRIKA’s monitors are experienced Clinical Research Associates (CRAs) based throughout the U.S. and Europe. By using a combination of in-house and regionally based CRAs, PROMETRIKA is able to minimize travel expenses while utilizing staff with extensive training and field experience. Our CRAs work closely with the Program/Project Managers to meet our clients’ expectations and deliverables.  This may consist of stand-alone services, such as monitoring a clinical site, or the full set of services associated with managing a study from inception to reporting.

Our CRAs are experienced in all aspects of clinical trial monitoring including:

  • A variety of therapeutic areas
  • Phase I – IV
  • Drugs, Devices, Biologics
  • All facets of Monitoring Visits
    • Site Qualification
    • Site Initiation
    • Interim Source Document Verification
    • Site Closeout

PROMETRIKA’s Clinical Monitoring professionals can provide all or a selection of the following services:

  • Clinical Monitoring Plan Development
  • Model Informed Consent Development
  • Site Instruction Manual Development
  • Investigator Identification and Selection Process
  • Clinical Site and Vendor Audits
  • IRB/EC Submission Management
  • Regulatory/Study Site Document Management
  • Investigator Meeting Coordination
  • Source Document Verification
  • Clinical Study Product Accountability
  • Investigator Contract Management and Payments