Clinical Trial Services
Clinical Research Services for Your Entire Trial
Full Service Clinical Trial Expertise
Our experts can provide guidance for key components of your program or completely conduct your project with full-service clinical trial capabilities. Whatever the scale or location of your trials, CompleWare’s expertise ensures your research is conducted efficiently, effectively and completely.
Our strategic guidance prepares you to execute sound clinical research that fulfills all regulatory guidelines and adheres to timeline and budgetary constraints. Whether you’re looking to draft and implement your clinical study protocol (CSP) or you need expert insight to evaluate your current protocol, CompleWare ensures your design is primed to direct a successful trial.
Successful development programs hinge upon a critical element: data. Complete trials rely on complete data, so rely on CompleWare for comprehensive clinical trial data management services. Our data management capabilities are enhanced from our innovative eClinical software, CompleClinical. From capturing and validating, to sorting and reporting, we ensure your global site data are accurate, secure and available on demand through a single point of access any time you need them. This is paired with an experienced clinical data management team with extensive backgrounds in respiratory and other therapeutic areas.
Data management capabilities:
- Data review, interpretation and clarification
- Data management plan (DMP)
- Database programming, verification and validation
- Radiological image analysis
- Spirometry collection and central review
- Query generation and resolution
- Clinical laboratory data integration
In every project we undertake, we appoint experienced project managers who pay attention to the details that drive on-time and on-budget product development. We focus on keeping an open flow of communication throughout the development process to increase productivity and ensure everyone involved is on the same page.
Project management services:
- Study initiation, oversight and close-out activities
- Investigator, site and/or site network recruitment
- Investigator meeting planning
- IRB and essential document review and management
- Central laboratory selection and integration
- 24/7 live help desk support
- Central study master file creation and maintenance
- Investigative site management
- Monitoring: qualification, initiation, routine and close-out visits
Along with our comprehensive data management software and clinical trial services, we quickly and efficiently generate clinical study reports to finalize your studies. Our writers are experienced in diverse therapeutic areas and ensure thorough and precise documentation, clarification and presentation of your findings. We also make certain your reports adhere to the ICH E3 regulatory guidance to facilitate smoother review.
The right statistical resources guide and expedite complete programs. But it takes an expansive knowledge base and solid grasp of what the development landscape entails to understand how and where biostatistics are best applied. CompleWare biostatisticians are skilled in everything from protocol design, to helping prepare all-inclusive regulatory submissions. We understand how to work as an extension of your team to pinpoint methods that will optimize your program. Our biostatisticians quickly interpret your data and generate actionable information throughout the life of your trial.
- Evaluation of safety and efficacy data
- Biostatistical analysis plan (SAP) (development, review and implementation)
- Biostatistical analyses (including listings, meta-analyses and reporting)
Consult An Expert
Find out how we can help see your project through from concept to completion.