Clinical Data Management Services

The increasing role of a dedicated Clinical Research Organization in your company's clinical data requirements

At Flatworld, our clinical data management and consultancy services are dedicated to providing you your clinical data, data analysis, regulatory support and presentation requirements.

Within clinical data management, optimal therapeutic designs, customer support and customized data analysis are key areas where our biostatisticians and medical writers interact to provide comprehensive solutions.

Only through an all-inclusive understanding of study objectives, clinical design issues, and upgraded quality control measures, can maintenance of the quality of data and adherence to expected deadlines be achieved.

Analysis of clinical trials includes pharmacokinetic and dynamic evaluations, therapeutic equivalence testing and sequential designs.

We have a talent pool of domain experts who understand your needs in bioinformatics and cheminformatics.

Read about Flatworld's scientific KPO for drug discovery here.

Our Clinical Data Management Services

• Clinical Data Entry
• Data receipt, logging and tracking
• Ongoing data entry from CRFS
• Data entry cleaning
• Custom database generation and design
• CRF/Data Development
• Clinical Data transfer
• Clinical Data quality assurance
• Case report form design, production, and tracking
• Case report form review
• Analysis of notes on CRFS and data alerts
• Reviewing consistency of medical and scientific data
• Clinical Database locking
• Automatic edit checking and query tracking
• Final and interim database locks associated with concerned documentation
• Medical Coding
• Coding of adverse events (meddra, who-art, costart)
• Coding of concomitant drugs (who drug centralized data coding)

Clinical Data Analysis / Biostatistics

• Clinical Study Randomization
• Dynamic Randomization
• Analysis Programming
• Interim/Sequential Analysis
• Periodic clinical data monitoring and safety reviews (DSMB)
• Statistical consulting
• CDISC clinical Data Compliance

Clinical Study Reports and Manuscripts / Medical Writing Services

• Clinical Research Reports
  • Statistical Reports
  • Integrated Clinical Study Reports (ICH template, as per FDA's CTD)
• Interim and final efficacy reports
• Safety/Data monitoring reports
• Integration of Safety and Efficacy Reports
• Review of medical and scientific reports on post-hoc/exploratory analyses
• Manuscripts and Abstracts
  • Manuscript editing for publication
  • Graphics and visual representations

Our Consulting Services

• Clinical Study Design and Protocol Evaluation
• Regulatory Support
• Safety Surveillance Services / Pharmacovigilance
• Clinical data Validation services

Clinical Study Design and Protocol Evaluation

• Feasibility Studies and analysis of potential clinical research programs
• Development of plans for clinical trials
• Protocol writing
• CRF designing
• Sample size determination for Clinical Trials
• Clinical Research Program Study design
  • Analysis of pre-clinical and Phase I-IV clinical proposals.
  • Evaluations of various designs to achieve the objectives of the clinical trial.

Regulatory Support

• Regulatory Support
  • Enabling parent company to make certain that it has conformed to the latest regulatory guidelines and regulations
  • Endorsement of NDAs and electronic submissions
• Contribution and interface with Clinical Data Monitoring Boards and advisory panels
• Presenting and supporting customers with third parties or regulatory bodies P
• Preparation of IND , IDE, MAA, NDA, PMA and 510k
• Regulatory Submission and Reporting

Safety Surveillance Services / Pharmacovigilance

• Integrated Safety and Efficacy Databases / Safety Database Management
• Ensuring and developing clinical data safety databases for point of reference as well as inclusion of key patient data
• Prompt reporting of serious adverse events (SAEs)
• Receipt/Review/Dissemination/Entry of SAE
• Safety Monitoring and Assessment
• Reconciliation with CRF
• Designing and executing a quality system that meets regulatory requirements
• IRB and Ethics committee approvals

Clinical Data Validation Consulting Services

Documentation of a process that complies with predetermined stipulations constantly

• Validation Project Management and Requirements Consulting
• GAP Analysis
• SOP development and review
• Test Script Development and Execution

For clinical data management solutions, outsource to us.