Clinical Data Management

OCT offers a full range of data management services, as well as clinical trial support at any stage of implementation — from early phases to post-registration studies

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At OCT, we understand that reliable data is the backbone of every successful trial. Our dedicated Data Management team works closely with sponsors to ensure that every data package is delivered on time, with uncompromising quality and precision — tailored to your specific study objectives.

Our commitment to excellence is validated by rigorous internal and external audits, which consistently demonstrate that our EDC and Data Management processes are fully compliant with all applicable regulations, including those of the FDA, EMA, national health authorities, and local regulatory bodies across countries where we operate.

User-friendly platform, real-time access, minimal site burden
Experienced data managers, proactive issue resolution
Standardized procedures, audit-ready documentation
Proactive quality control, risk-based monitoring
Statistically-valid data, regulatory-ready evidence

What Really Sets OCT’s Offering Apart

OCT platform
Proprietary EDC/IWRS platform
21 CFR Part 11 compliant • audit trail down to the field level
CDISC support for regulatory submissions
Integrated Randomization and Trial Supply Management
Real-time coding, reporting, and listings
DM services – OCT team
FDA and EMA submission experience
A rarity for a local CRO
50+ external audits
With no critical findings
250+ completed projects
A rapid start-up
Single point of accountability
Platform + people + process under one roof
Flexible sales models
What most full-service CROs avoid

Maximize efficiency of capturing and managing data in a unified, reliable and secure system

EDC/IWRS
EDC/IWRS
  • User-friendly interface
  • Integrated randomization system
  • Bilingual application
  • Uploading and storage of digital images and other types of files
  • Automatic checks
  • Laboratory module
  • Medical data coding according to the WHODrug Global and MedDRA dictionaries
  • Reports
  • Automatic notifications
  • Visit tracker
Trial Supply
Trial Supply
  • Integrates with EDC/IWRS
  • Transparent drug logistics
  • Automatic and manual supplies
  • Distribution of medication among subjects according to treatment groups
  • Online inventory
  • Automatic notifications
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Data Management Service Packages

Choose the level of support that matches your study level. Every tier is built on the same rigorous, validated procedures.

Data Management Service Tiers
Basic
Optimum
★ Most popular
Premium
Full oversight
Best for
Small, single-site studies
Standard multi-site trials
Trials needing hands-on oversight
EDC platform
License and hosting included
Same as Basic
Same as Basic
eCRF Setup & Design
eCRF design, database build, DM study plans & documentation
Same as Basic
Same as Basic
Training & Access
CRF Completion Guidelines, user training & access management
Everything in Basic
+ Extended Site Training Package
Everything in Basic
+ Extended Site Training Package
Technical Validation
Full EDC & eCRF technical validation package
Same as Basic
Same as Basic
Data Cleaning & Quality
Edit checks, ongoing data review, query resolution, medical coding, external data reconciliation
Same as Basic
Same as Basic
Reports & Listings
Standard EDC reports
+ 3 custom data review listings
Standard EDC reports
+ 5 custom data review listings
+ Final Data Management Report
Standard EDC reports
+ Custom EDC reports
+ unlimited listings (scoped at study start-up)
+ Final Data Management Report
+ bi-weekly progress reports
Database Lock & Archiving
DBL, data transfer & archiving process
Same as Basic
Same as Basic
Support
Standard business-hours support
Standard business-hours support
Standard business-hours support
+ 24/7 support on request
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Why Our Clients Choose Us

“We are pleased with OCT’s ability to meet our data management needs within our timeline”

“The results OCT has been demonstrating as the principal CRO for the project were outstanding”

“The OCT team met our goals under very difficult conditions. The achievement is quite impressive, considering the challenging circumstances imposed by the global pandemic”

Talk to an Expert

Behind every successful clinical trial lies a solid data management strategy. Discover how we can enhance your clinical study

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