Data Management Services for Clinical Trial

1
Clinical Trial Data Management Services

• Genpro offers an experienced clinical data
  management services, team of managers and
  clinical data coordinators who comes with a life
  science background. They are trained in ICH/GCP
  as well as CFR PART 11 guidelines. Genpro has
  extensive experience in various EDC tools and
  provides EDC setup services to different phases
  of clinical trials. As part of these services, we
  have acted as the data management centre and
  supervised the Data Collection, Query Management,
  Data Cleaning and Database lock. Genpro prepares
  a comprehensive data management plan (DMP) which
  is a road map to handle the data under
  foreseeable circumstances and describes all the
  CDM activities to be followed in the trial. We
  have also been part of several data monitoring
  committees which oversaw the process with various
  sponsors.

2
Our Key Services

• 1. DATA MANAGEMENT PLAN
• Comprehensive data management plan which explains
  all the components of the Data Management
  process. We deliver a comprehensive data
  management plan (DMP) which explains all the
  components of the Data Management process
  starting from the CRF Design to the Database
  Lock on a clean and error free database
• 2. DISCREPANCY MANAGEMENT
• Query Resolution compliant to the study protocol.
  All manual or auto-generated queries/
  discrepancies need to responded to and resolved
  by corresponding site personnels. Thus, the
  discrepancy management make sure that the data is
  complete, accurate, and compliant with the study
  protocol.
• 3. DATA VISUALISATION
• Interim monitoring of trial through data
  visualization dashboards. Clinical Data
  Visualisation and constant monitoring of data
  forms an integral part of clinical data
  management these days. Genpro used visualisation
  tools like TIBCO Spotfire, Tableau and Qlikview
  to provide visualisation services to our
  customers.

3

• 4. DATA MONITORING COMMITTIEES
• Complete data monitoring package and DMC
  representations. We offer a complete data
  monitoring package which involves, organisation,
  set up, unblinding, production of data packages,
  database backup and recovery and interim data
  analysis. We have experience organising data
  monitoring committees worldwide.
• 5. DATA VALIDATION
• Ensure the quality and integrity of data through
  effective validation. The two step process, Data
  Validation and Cleaning ensures the quality and
  integrity of the data which is provided for
  analysis. The validation checks created for all
  study end points helps to identify the
  inconsistencies and potential errors.
• 6. CRF DESIGN
• Clear and Concise CRF which capture study data to
  its fullest. Quality of the data relies on the
  quality of data collection instrument- (CRF). We
  make sure that the questions and instructions
  provided in the CRF is clear and concise

4

• 7. DATABASE LOCK
• Standard pre-lock checklists will be executed
  prior to database lock. Once the discrepancy
  management activities are over, based on a
  pre-lock checklist the final database lock is
  carried out. Final data extraction is carried out
  and provided for data analysis.
• 8. EDC SETUP
• EDC experience across multiple platforms,
  therapeutic areas and study phases Complete data
  monitoring package and DMC representations. Our
  EDC Setup and Development service includes the
  design of Case Report Forms, CRF completion
  guidelines , Trial database setup, Validation
  checks, data extraction,and the database lock on
  the clean database.

5
Our Mission

• Our mission is to support our clients in
  achieving their goals by providing knowledge
  driven innovative solutions with highest quality
  products and services.
• WHO WE ARE
• Genpro Research is a next-generation services and
  technology partner for the pharmaceutical,
  biotechnology, and medical devices industry. Our
  tools use Artificial Intelligence, Machine
  Learning, and Natural Language Processing
  algorithms to enable automation of several
  processes in a drug development pipeline.. We
  provide advanced solutions in Biostatistics
  Programming, Medical Writing, and Regulatory
  Submissions.

6
GET IN TOUCH WITH US Follow Us On Social
Networks Facebook Twitter LinkedIn C