Clinical Data Management (CDM) is a critical phase in Clinical Research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials and we, at Velocious Clinical Research adopted best industry practices to deliver high-quality data within committed timeline wherein our client can make decisions earlier in the trial that ensures the patient safety and reliability of the results.

Our Process

Process Icon Process Icon

Defined SOPs for all processes

Process Icon Process Icon

Faster and efficient database built-up

Process Icon Process Icon

Follows standards like CDISC- CDASH/ SDTM

Process Icon Process Icon

Robust validation checks to deliver error free database

Process Icon Process Icon

Real time data review and reconciliation of the external data

Process Icon Process Icon

Early identification of project / site trends and advising mitigation actions

Process Icon Process Icon

Quality Control on each data handling process to ensure validity and integrity of the data

Process Icon Process Icon

Quality Assurance process further assures the quality of the data as per the regulatory requirements and SOPs

Process Icon Process Icon

A strong cross functional & proactive communication to ensure database lock is achieved within the pre-defined time frame

Our Clinical Data Management service includes following task (Integrated/ Standalone) :

  • Case Report form (CRF)development
  • CRF Completion guideline development
  • Data Management Plan development
  • Database Designing in accordance with regulatory guideline and standards like CDISC - CDASH/ SDTM
  • Edit Check Specifications (ECS)and Programming
  • User Acceptance Testing (UAT)
  • User Access Management
  • CRF Tracking and Scanning
  • Double Data entry, Paper based studies
  • Data Validation and Query management
  • Medical coding using standard dictionaries like MedDRA, WHODrug
  • Quality Control on each data handling process
  • Quality Assurance audits
  • External Data Reconciliation like Laboratory data, Serious Adverse Event (SAE)
  • Lab Normal Management
  • Database Lock
  • Data Output for statistical analysis
  • Diversified use of different EDC platforms based on the client requirements
  • Customized services as per project specific requirements e.g. Only Data Entry

Data Management System Experience

We have the dedicated team of Clinical Database programmer having significant experience in building the database and managing the data using various EDC platforms.

Our team is experienced on following Clinical Database :

  • Oracle Clinical
  • ClinTrial
  • Octalsoft
  • Amedon
  • Acceliant
  • BizNET CTM
  • Ease to adopt any 21 CFR Part 11 CDMS as per client preference
  • ClinDox-CRFWeb
  • ClinVigilant

Therapeutic Experience

Clinical Data Management team has extensive therapeutic experience in paper as well as in EDC study across all therapeutic areas namely,

  • Oncology (27)
  • Psychiatric Disorders (11)
  • Dermatology (11)
  • Musculoskeletal Disorders (10)
  • Genito-Urinary Disorders (9)
  • Haemato-Oncology (8)
  • Metabolism and Nutrition Disorders (6)
  • Eye Disorders (4)
  • Vaccines (4)
  • Infections (4)
  • Haematology (2)
  • Nervous system disorders (2)
  • Gastroenterology (2)
  • Vascular Disorders (2)
  • Other (2)
  • Immune System Disorders (2)
  • Respiratory Disorder (1)
  • Cardiac Disorder (1)
  • Hepatobiliary Disorder (1)
  • Injury and Procedure (1)
  • General (1)
  • Endocrine Disorder

Regulatory Submissions

  • DCGI (48)
  • USFDA (41)
  • None (11)
  • EMEA (4)
  • Turkey (4)
  • Registry (2)
  • ANVISA (1)
  • FDA (1)
Contact Us