Clinical Data Management

CDSA collaborates with Government Agencies, Academic Institutions, Small and Medium Enterprises (SMEs) in Pharmaceutical, Biotechnology and Medical Device sectors and provides customized Clinical Data Management (CDM) services. This includes, but not limited to the following:

  1. FTE (Full time equivalent) manpower support for the projects.
  2. Project based customized CDM SOPs.

Currently, CDSA-CDM is managed by Ms. Vineeta Baloni under the supervision of Dr. Nitya Wadhwa and provides end to end support of CDM activities – CRF development to database lock on Promasys v7.3 and supports both Paper based and browser based WebCRF. Support to project teams for data Management setup, database UAT, study related documents preparation and maintenance & reports generation.

CDSA has upgraded version of Promasys v7.3 in a secure and validated environment, ensuring quick and smooth transition of data from Data Management Centre to the Biostatistician for the analysis. Promasys has various interfaces for data entry, from data entry screens in the windows client, to the client-based eCRF, the browser-based WebCRF, and the Promasys iPad app.  Promasys has also been mapped with MedDRA dictionary to enable medical coding. Depending on what the study protocol prescribes or the sites preference, data collection can be in any combination of data entry interfaces.

Upgradation of Promasys v7.2 to Promasys v7.3 in a secure and validated environment has been done. Main features of Promasys v7.3 are as follows:-

Promasys iPad app – Innovative Mobile EDC System

  1. Location-free data collection using WIFI or Cellular internet connection
  2. Subject registration as well as visit scheduling using the planning module
  3. Interface optimized for mobile data collection
  4. Jump directly to subject information page or specific data item through barcode scanning
  5. Direct image data upload to EDC and viewing/downloading
  6. Full electronic signature functionality as well as audit trail viewing available directly from iPad

WebCRF – Platform-free Data Entry Interface using standard internet browsers

  1. Subject registration and data entry without having to install an application
  2. JQuery base: supports all current major browsers
  3. Rich CDMS functionality allows for efficient and quality data collection in multi-center research
  4. Print CRFs and Data Entry Progress reports, and export datasets directly from browser
  5. Direct image and PDF data upload to EDC and viewing/downloading
  6. o  Full electronic signature functionality as well as audit trail viewing available directly from browser

Extensive Library of Reports

  • Promasys comes standard with an extensive library of more than 70 reports: from subject recruitment progress reports to audit trail listings or data entry progress reports.

Easy Access to Full Audit Trail

  • All changes in variable values as well as trial design are tracked in the system-generated audit trail.

Fully Configurable Access Control

  • System access control is managed based on user ID and password.

 Simple Workflow

  •  GCP compliance is supported through the Study Life Cycle™, Promasysʼ quality engine that divides a clinical trial in 7 distinct phases.
  • Access rights of users are dynamically adjusted when the phase of a trial changes. Quality and integrity of data are guaranteed with minimal user intervention.

Coding Systems

  • The Promasys Coding Systems option provides a connection to standard coding databases, MedDRA, WHODDD, ATC/DDD and allows the user to perform coding of adverse events and concomitant medication from within the Promasys interface.

Import of HL7 messages

  • Promasys can capture of HL7 messages, allowing for automatic import of e.g. lab data.

Job Scheduler

  • Reports can be generated in the background and distributed to specified users as email attachment.

 SDTM Export

  • Trial Master has a powerful mapping tool that can be used by Promasys to export SDTM datasets.

ePRO

  •  Patient Diaries and other patient reported data can be collected directly from the patient’s own smartdevice using Promasysʼ ePro (Electronic Patient Reported Outcome) capability.

CDSA is gearing up to provide the following CDM services through its data management department:

  1. CRF Development
  2. Development of Annotated CRF
  3. Data Management Plan
  4. Data Validation Plan/ Edit Checks Specifications document
  5. Database development
  6. eCRF Completion Guidelines
  7. Coding of AE (MedDRA)
  8. Coding of Concomitant Medications (WHODD)
  9. SAE data reconciliation
  10. Audit Trail
  11. Third Party Vendor Data Import Set-up (Central Lab, ECG etc.)
  12. Design and Program Data Listings (for Sponsor Review)
  13. Create and Provide Patient Profiles (for Sponsor review)
  14. Database lock (final analysis)
  15. Data backup & Archival
  16. Transfer of Database to Sponsor
  17. Electronic Signatures functionality
  18. Customized reports
  19. Compliance with FDA regulations, in particular 21 CFR part 11.

Currently, CDSA has been providing CDM services for the following studies:

Project NamePrincipal InvestigatorCDM role in study
Immediate Skin-to-Skin Contact (Immediate Kangaroo Mother Care) Study (WHO/BMGF)Dr. Harish Chellani1. Case Report Form (CRF) designing and finalization.
2. Performed User acceptance testing (UAT) of iKMC database in RedCAP software.
3. Oversight of all CDM activities.
4. Providing templates and logs to data manager and data entry operators for tracking of all the records.
5. Support to Data manager and clinical team for the data review presentations with WHO.
6. Supervision for Data entry, data merging and Quality check of data.
A Phase IV, Interventional, Open label, Multi-centric, Single arm clinical trial to assess the Safety, Tolerability & Immunogenicity of Bivalent Oral Polio Vaccine (bOPV) in healthy Indian infants.Mr. S. K. Tyagi (BIBCOL)1. Protocol specific Case Report Form (CRF) designed and finalized.
2. Data management for this study is being done using PROMASYS clinical database with built-in edit checks and validations.
3. Preparation of data management documents viz. Annotated CRF, Edit checks document/ Data Validations Plan and Data management plan.
4. Database development in Promasys v7.2.
5. Training to project staff for data entry, query generation and query resolution, review and approval of data.
6. Query management, Data cleaning and data freezing is in process.
7. DSMB to be conducted on 16th Oct 2018.
CDSA has successfully completed CDM services for the below mentioned studies (from CRF development to Database lock and archival):
Evaluating the efficacy and safety of an innovative and affordable Goat Lung Surfactant for the treatment of respiratory distress syndrome in preterm neonates: a multi-site randomized clinical trial.Dr. Ramesh Aggarwal1. Data management for this study is being done using Acceliant eClinical suite (Trainz Ltd.) with built-in edit checks and validations.
2. Coordination in preparation of data management documents viz. Annotated CRF, Edit checks document/ Data Validations Plan, Data management plan, CRF filling guidelines and database development.
3. Training to site staff for data entry and query resolution.
4. Performed Query management, Data cleaning and data freezing.
5. As per discussion in DSMB, study will be terminated by May 2018, so the final database locking and archival has been done.
A Phase II, Open Label, Randomized, Clinical Trial to Evaluate the Anti-Bacterial Activity, Safety, Tolerability and Pharmacokinetics of a Combination of PA-824, Moxifloxacin and Pyrazinamide, or PA-824 When Administered with the Category IV Regimen of RNTCP in Adult Patients with Newly Diagnosed Multi-Drug Resistant Pulmonary Tuberculosis.Chief Coordinating Investigator: Dr. Soumya Swaminathan



Principal Investigator: Dr Rupak Singla, Dr. Rohit Sarin & Dr. C. Padmapriyadarsini
1. Protocol specific Case Report Form (CRF) designed and finalized.
2. Data management for this study was done using PROMASYS v7.2 with built-in edit checks and validations.
3. Prepared data management documents viz. Annotated CRF, Edit checks document/ Data Validations Plan and Data management plan.
4. Database developed in Promasys v7.2
5. Training to project clinical database manager for data entry, query generation and query resolution.
6. Performed Query management, Data cleaning and data freezing.
7. Done Final Database lock and archival of data.
PTB Surveillance Phase I of Surveillance to support Inter-Institutional Program for Maternal, Neonatal and Infant Sciences: A translational approach to studying Preterm Birth.Principal Investigator:
Dr. Shinjini Bhatnagar
1. Prepared Case Report Form in PROMASYS v6.2 with built-in edit checks.
2. Training to project staff for CRF filling and quality control for data management has been imparted to ensure the quality of data.
3. Prepared and maintained data management documents viz. data management plan, edit checks document, CRF filling guidelines, QCFs logs and trackers.
4. Performed Query management, data cleaning & data freezing.
5. Data archival in Promasys v6.2 and handed over the data in excel format to the PI.