IVD and CDx
Clinical Trial Services
There are many unique requirements for successful in-vitro diagnostics (IVD) product development – including aligning product specifications with customer needs, resource planning, assay development, and regulatory requirements.
Whether your research plan requires 1 or 100,000 biospecimens, ProMedDx provides the comprehensive services you need to support your IVD and biomarker research.
ProMedDx has more than 20 years of experience supporting innovative IVD products from concept to market. Our comprehensive knowledge of the process, regulation, and commitment required to execute IVD and biomarker research collections effectively is available as a suite of contract services on which you can build your research plan.
Research shows that 80 percent of all clinical trials fail to meet their enrollment goals. Nearly half of those are the result of poor site selection and ineffective recruitment techniques.
The experienced ProMedDx project team works across most therapeutic indications to ensure your study is supported by the highest-qualified sites, with trained staff focused on exceeding your expectations:
- Experienced network of study-ready investigators
- International and domestic
- New site identification
- Site assessments
- Laboratory/processing evaluation
- Quality and regulatory focus
- Investigator agreements
- Recruitment evaluations and best practice strategies
- Competing study analysis
The success of your research study doesn’t stop with quality site selection. In fact, that’s just the beginning. ProMedDx expertise streamlines the process of document design including:
- Development of detailed clinical collection protocols
- Informed consent forms (multi-lingual)
- Case report forms (CRFs) including eCRFs
- Specimen testing data case report forms
- Investigator brochures and agreements
- Analysis of patient population – diseased and healthy cohorts
ProMedDx maintains in-house regulatory expertise to ensure your project meets the latest informed consent criteria for the intended use of the research specimens you are collecting.
- Domestic and international experience
- Preparation and submission of IRB/Ethics Committee documentation
- Analysis of regional and international informed consent restrictions
- Intended and future use considerations of biospecimens
The ProMedDx foundational infrastructure of facilities, staff, and IT systems contributes to the successful implementation of your project within the investigational sites.
- Site manuals (paper and electronic)
- Collection study kits
- Study documents o Reference testing forms
- Study documents
- Consent forms
- Tracking logs
- Study kits
- Specimen processing instructions
- Shipment materials
- Staff training and qualification
- Interim training workshops (i.e., recruitment strategies, processing efficiencies, regulation trends)
- Site initiation
- Real-time enrollment tracking and reporting
Our team of Certified Clinical Research Associates (CCRAs) specializes in monitoring IVD and biomarker clinical collection studies.
Our centralized monitoring system enables real-time, effective management and oversight of the site and conduct of the study in order to anticipate trends, and ensure the protection of patient rights and biospecimen viability in both small- and high-volume enrolling sites.
- Site initiation
- Consent verification
- Source document review
There is inherent variability in the skills and facilities across multiple investigative sites. Still, these variables can impact biospecimen integrity – and the intended outcome of your research plan.
The ProMedDx clinical project team works with you to determine the unique characteristics of your research and investigative sites – then customizes collection, processing, transport, and storage solutions to integrate seamlessly into the workflow of the site and to ensure the viability of every biospecimen collected.
- Comprehensive biospecimen collection, processing, and storage instructions
- Study-specific collection kits and processing supplies
- Monitored short-term storage at all thresholds
- Shipping logistics
ProMedDx ensures that your assets are accessible for on-demand retrieval and shipment while maintaining required temperatures and chain-of-custody as specified in your protocol.
Logistics for domestic and international shipping:
- IATA-, DOT-, and ICAO-compliant
- Coordination and facilitation of import and export permits
- All assets (specimens, study collection kits, and study supplies
- 21 CFR 11-compliant, fully auditable
- Chain of custody
- Sample Collection (Draw to Destination)
- Retrieval & Reporting
- Short and Long Term Storage
- Web portal
- Inbound/outbound scheduling, tracking, and shipment management
- Coordination with companion reference testing sites
Clinical Data Management (CDM) is a critical phase in every clinical research initiative, but one that can pose technology and budget challenges. Our fully auditable ProMedDx Rockhopper™ specimen management system is 21 CFR 11-compliant, and assures the quality and reliability of data points and integrates seamlessly with supporting systems – delivering unequaled confidence in the data that supports your clinical research.
Biostorage solutions are not a “one-size fits all.” ProMedDx offers customized biospecimen storage and distribution services that are efficient, compliant, and meet your unique biostorage needs.
Ensuring the Quality of Your Research
You can trust in our experienced ProMedDx project managers and expert IVD and CDx clinical services to ensure the quality of your clinical research projects.