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CRO Services
Clinical Research & Regulatory Strategy
DCN Dx specializes in comprehensive clinical research, trial
management, and regulatory support. With in-depth point-of-care
expertise, turn to us for specific guidance on your IVD project.
The Team Behind Your Team
With decades of hands-on experience, DCN Dx’s CRO experts act as an extension of your team, managing every aspect of your IVD clinical trial—study design, biostatistics, data management, and regulatory pathways—to ensure the success of your device.
The Proof is in the Partnership
Clinical Research Services
Trial Management
01
DCN Dx’s team expertly manages IVD clinical research from study design through regulatory submission, ensuring your trial meets GCP, GLP, HIPAA, and regulatory standards at every stage.
Site Development
02
We strategically select and qualify clinical trial sites to ensure diverse representation and timely milestones for IVD studies. Our team has extensive experience managing both enrolling and laboratory sites.
Biostatistics
03
Our in-house biostatisticians collaborate with your team to ensure study validity, compliance, and precise data analysis for your IVD clinical trials.
Data Management
04
Our data management team ensures the accuracy, security, and regulatory compliance of your IVD clinical trial data, safeguarding the integrity of your study from start to finish. This includes seamless electronic trial master file (eTMF) management with Veeva eTMF and comprehensive clinical data oversight using Veeva CDMS.
Regulatory
05
With deep expertise, we develop clear regulatory pathways for your IVD device, streamlining the process to save time and costs starting as early as feasibility.
Consulting
06
DCN Dx provides expert guidance at every stage of IVD development, offering technical, regulatory, and business insights to accelerate your product’s readiness for regulatory approval.
Ready to Get Started?
Select the services you’re interested in and a representative will reach out to you to discuss in further detail.
Our Expertise
.01
Complete, comprehensive clinical study process
Site identification and qualification
Site contracting and management
IRB/ethics committee management
Monitoring from pre-study qualification through closeout
.02
Protocol composition and consulting
.03
Electronic trial master file (TMF) (Veeva eTMF)
.04
Comprehensive clinical data management including Veeva CDMS
.05
In-house biostatistics services (SAS programming)
.06
Study kitting, supply, and investigational product management
.07
Early feasibility studies
.08
Usability and reproducibility studies
.09
Clinical and regulatory strategy
.10
Integrated R&D department
.11
KOL selection and panel oversight
Your Clinical Research Roadmap
Engage DCN Dx on one or all of the following steps.
01
study
startup
- Project management throughout the trial
- Study design and protocol/ICF writing and/or review
- Statistical analysis plan
- Site identification & qualification
- Site contracting
- IRB/EC submission
- Regulatory document development
- Database development
- Trial master file (TMF) creation
- Acquisition of study supplies
- FDA pre-submission (if applicable)
- Regulatory submissions
02
study
initiation
- Finalizing essential documents
- Obtaining IRB approval
- Site selection
- Site training and initiation
- Device distribution and management
03
oversight
& monitoring
- Site monitoring visits
- Protocol adherence and documentation
- Data monitoring
- Regulatory and investigator communication
- Safety oversight
04
study
closeout
- Data lock and final analysis
- Report writing and regulatory submissions
- Site closure and archiving
Clinical Research Insights
Next Steps