Many CROs and Sponsors seeking spirometry services for a respiratory clinical trial recognize the value of subject matter expertise and an innovative technology platform. Those aspects are crucial, of course, but they may not be the whole story. You need a partner that not only delivers fast access to Registered Respiratory Therapists (RRTs) and a secure, end-to-end spirometry capture platform, but also has the clinical operations experience to drive study milestone achievement. And it all must be based on a robust, foundational quality assurance program. You need the whole package. You need a clinical endpoint expert.
Here are the top four reasons to partner with a clinical endpoint expert for your next respiratory trial:
1. SUBJECT MATTER EXPERTISE
- Study Design Insights. The subject matter expertise brought by a clinical endpoint expert delivers everything from protocol design insights to integration of regulatory guidance with protocol and study needs. A team of SMEs can also offer advice on clinical endpoints and surrogate endpoints. The early involvement of SMEs in the design of your protocol and clinical data collection process can greatly enhance the success of your study.
- Centralized Spirometry Review and Grading. Centralized review by a team of RRTs using configurable, standardized grading to confirm and adhere to protocol and ATS/ERS standards can greatly reduce variability in spirometry data.
2. TECHNOLOGY PLATFORM
- Cloud-based, Configurable Data Capture Platform. A centralized data capture system provides streamlined data acquisition and grading of spirometry data for respiratory clinical trials. A 21-CFR Part 11 and HIPAA-compliant platform with customizable workflows and audit trail tracking can simplify and streamline the respiratory clinical trial process.
3. CLINICAL OPERATIONS
- Standard Processes and Comprehensive Instructional Materials. Standardized processes for site qualification, instruction, and certification reduce the site management burden. All users must be provided with clear instructional materials including manuals, videos, and webinars.
- Project and Site Management. Clinical operations’ project and site management, coupled with high-quality site support, can increase site engagement. Sponsors benefit with improved subject qualification and retention at screening and throughout the study. Sites and partners should have both swift access to RRTs, and the ability to draw on an entire project management team.
- Site Technician and Equipment Certification. The site technician and equipment certification provided by clinical operations ensures the readiness of sites for study start up. The process should include detailed software user manuals and spirometry collection procedures per the protocol. Clinical operations can offer supplemental performance information about a potential site based on prior experience.
4. QUALITY ASSURANCE
- Regulatory Compliance, Data Privacy & Security. Quality Assurance must form the cornerstone for a clinical endpoint expert’s successful management of clinical trial data. They should be ISO 13485 and ISO 27001 certified and have experience with regulatory agency inspection and vendor auditing by sponsor companies. Their technology platform needs to be HIPAA compliant and meet all 21 CFR Part 11 requirements for electronic records and signatures.
WHY MERIT?
MERIT has the proven respiratory experience to help you accelerate your product development. Our specialized expertise informs every facet of our relationship with you, making our partnerships simpler and more efficient. If you’re looking for a spirometry services provider that will value your partnership and make your study a priority, consider MERIT.
Learn more about our respiratory solutions.
WHY MERIT?
Gain assurance with our proven track record providing reliable endpoint expertise to 12 of the top 20 global pharmaceutical companies
Reap the benefits of competitive pricing and shortened timelines resulting from efficiencies gained over decades of experience
Benefit from transparent communication and prompt access to in-house experts
Reduce clinical trial risk. Our experienced team delivers risk management by anticipating your study challenges
Increase your trial’s flexibility with our scalable solutions. We adapt quickly to your changing needs
Rely on MERIT consistently meeting customer and regulatory requirements as validated through our ISO 27001 and ISO 13485 certifications
Simplify and streamline your pulmonary clinical trial process with CompleClinical®, MERIT’s innovative spirometry software application
Some companies tend to overpromise and underdeliver, which puts your study success at risk. If you’re looking for a clinical trial endpoint services provider that will value your partnership and make your study a priority, consider MERIT.