No products in the cart.
CRO SERVICES
Clinical Trials
IVD-focused clinical trial management, from study startup through closeout, built for GCP compliance and submission-ready evidence.
Operational Control from Startup to Closeout
IVD clinical trials succeed when operations, documentation, and data capture stay aligned to intended use and regulatory strategy. DCN Dx manages your study end-to-end or provides specialized services, keeping timelines predictable and ensuring submission-ready data.
Our Expertise
Trial Project Management
01
Dedicated Clinical Trial Manager and clinical oversight to manage timelines, vendors, risks, and communications across the trial.
Protocol & ICF Support
02
Protocol and ICF drafting or review to align intended use, site workflow, and regulatory expectations.
Study Startup
03
Essential documents, TMF setup, IRB/EC submissions, site contracts, and study supply and kitting readiness.
Site Initiation & Training
04
Coordinate site initiation and training to standardize procedures across enrolling sites and laboratory partners.
Monitoring & Oversight
05
GCP-aligned monitoring verifying protocol adherence, documentation quality and data integrity.
Closeout & Archiving
06
Drive site closure, TMF completeness, and final deliverables including CSRs and regulatory submission packages.
Interested in becoming a partner site?
Trial Execution Aligned to Your Submission Strategy
We coordinate across in-house clinical operations, data management, biostatistics and regulatory to keep study execution, documentation, and final deliverables consistent through database lock and submission.
Project Types
Early Feasibility Studies
01
Operationally lean studies to confirm workflow, specimen logistics, and site readiness, building the foundation for a larger clinical program.
Clinical Performance Studies
02
Prospective and multi-site IVD studies executed to generate clinical performance evidence aligned to intended use and your submission pathway.
Human Factors & Usability
03
Study management for human factors validation and summative usability studies, with monitoring and documentation aligned to FDA HFE guidance and IEC 62366-1.
Reproducibility Studies
04
Multi-site coordination and monitoring for reproducibility studies, managing site procedures, sample handling, and data capture across operators, days, and lots.
Trial Rescue & Remediation
05
Targeted support to stabilize a challenged study, including remediation of monitoring findings, documentation review, and corrective action plans to protect data integrity.
Don’t See What You’re Looking For?
Why Choose DCN Dx?
.01
IVD-Specific Focus
We understand the science of diagnostic products, specimen-based studies, and the nuances reviewers expect in IVD clinical evidence.
.02
Compliance-First Execution
Trial conduct and documentation aligned to GCP and local regulatory requirements, so your study stays compliant and inspection-ready.
.03
Integrated CRO Services
Trial management connects directly to DCN Dx biostatistics, data management, and regulatory support to keep decisions consistent.
.04
Sponsor-Centric Partnership
Clear communication, practical problem-solving, and a flexible engagement model, whether you need a full program or support on specific workstreams.
Questions About Your IVD Clinical Trial?
Clear communication, practical problem-solving, and a flexible engagement model, whether you need a full program or support on specific workstreams.