Project Management

The right people assigned to the right project bring your product to market on time and on budget. ZTrials uses personal experience, tools, and properly applied technology. Our ZTrials support team works with your in-house staff or this can be fully outsource to us. We understand how to work with your team and vendors to execute your clinical trial.

Clinical Monitoring

ZTrials delivers clinical monitoring services that are protocol-specific. Our site network provides SOPs and standardized training for any number of sites and/or geographic locations. We will work with you to provide experienced individuals and teams worldwide to monitor all aspects of a trial. Also we can provide support to your existing team. Our Senior-level CRAs with high benchmarks in the industry are critical for professionalism and consistency. Experienced clinical research personnel deliver with efficiency and on-time data locks.

Data Management

The ZTrials clinical operations group works closely with the data management team for reliability and accurate clinical trial data collection. This is achieved by using our industry partners to perform standard electronic data capture (EDC). We have worked with many industry-known data management vendors. Our data integrity program and quality assurance oversight throughout the clinical trial provides proper data silos, and ensures security for authorized personnel.

Quality Assurance

Robust quality is our business. At ZTrials, we have built our program in accordance with protocols, written procedures (working documents), and Good Clinical Practices (GCP). Our quality services for our sponsor-clients are overseen for each ZTrials department. The key to quality is ongoing processes to ensure that ZTrials activities are properly being executed. Full transparency with their sponsor counterparts ensure oversight and quality from the time of study start-up to study closeout.

We also use independent Quality Assurance (QA) auditors to perform routine assessments. Our internal standard operating procedures (SOPs), Good Clinical Practices (GCPs), FDA regulations and ICH guidelines are incorporated into our standard business unit practices. This ZTrials department conducts internal audits, trial master file audits, and vendor qualifications audits to evaluate continual process improvement,¬† maintenance according to protocol. We pride ourselves in leaving “No Stone Unturned.” when it comes to QA.

Vendor Management

ZTrials can provide solutions for any clinical trial. Here are a few of the frequently used vendors:

  • Central labs
  • Central IRBs
  • Data management services
  • Statistical services
  • IVRS/IWRS/IXRS
  • Investigational product packaging/labeling/distribution, etc.
  • EDC platforms
  • eTMF
  • Meeting planners
  • Regulatory affairs
  • Pharmacovigilance

Regulatory Affairs

We’ve got the support! ZTrials provides full regulatory review¬†and support for studies and can help specific to the phase of development. We utilize certified individuals for their expertise of FDA and international regulatory policies. We update our internal SOPs and guidelines from industry standard providers to ensure the latest information is communicated across the enterprise.

The ZTrials Consulting Group

We provide services for sponsors:

  • Medic group and protocol or disease specific expertise
  • Writing: Protocol, Informed Consent, and CRF design and review
  • Regulatory advice, counseling, or support
  • IB-(Investigator brochure) for country specific
  • Laboratory, Medical Data Review
  • Safety Review or Consulting
  • Data Monitoring Committee (DMC and DSMB)