Data Management Services
Topstone Research takes pride in providing outstanding Clinical Data Management services, customized to your requirements by following ICH, GCP, and regulatory agency guidelines, using controlled and secure computing environments with validated software and systems (21 CFR Part 11 compliant) and well-designed workflow processes and procedures. We support your drug development needs by providing real-time, faster access to data, enabling you to make faster decisions and getting your drugs to the market as quickly as possible, while making patient safety a top priority.
Topstone Research adheres to current top industry standards. The use of Standard Operating Procedures, and the use of templates for standard CRF/eCRFs, Data Management Plans, User Acceptance Test documents, data review checklists, database quality acceptance sampling plans, database lock checklist sign-off sheets, etc. ensure consistent high quality. All data is captured according to CDASH standards, and goes through vigorous quality checks. Any discrepancies are resolved through full query management. From the onset, a protocol-specific Data Management Plan ensures quality guidelines are in place. Medical Coding is done according to internationally recognized MedDRA and WHO-DD, and any SAEs are managed through a safety portal and fully reconciled prior to database lock.
Our comprehensive clinical data management services include:
- Data Management Plan (DMP) development
- eCRF design and development
- Database Build & Design
- Data validation specifications
- Edit checks Programming & Testing
- EDC Training
- eCRF Completion Guidelines
- Query Management
- Third-party data integration
- Customized clinical data management programming
- Safety Data Management & Reconciliation
- Interim Analysis readiness
- Medical coding (CM, AE, MH)
- Serious Adverse Event (SAE) reconciliation
- Customized status reporting and data listings
- Data Export/Transfer
- Database closeout and delivery
Randomization & Drug Supply Management
Topstone is proud to offer full service IRT/IWRS system in collaboration with HMD Clinical. HMD Clinical have a longstanding working relation with Topstone.
We provide the following comprehensive services under one umbrella:
- Supply Management
- Subject Visits
- Randomization Schedules
- Randomization and Treatment Arm Assignment to Subjects
- Unblinding Module
- Accurate, real-time trial metrics
- Dedicated secure web portal
- Enrollment rates and supplies inventory
- Customized study specifications
- Seamless data integration
- Capturing Patient Reported Outcomes (ePRO)
- IWRS User Manual
- Dedicated support email
- 24/7 toll-free helpdesk support
Topstone’s highly qualified biostatistician and statistical programming team is fully dedicated to deliver high-quality, submission-ready data for regulatory agencies. Our team is skilled in the design and analyses of Phase I-IV clinical trials and will help you select the most appropriate strategy to meet the objectives of your study and the recommendations of all relevant regulatory bodies.
Whether the study design is parallel, factorial cross-over, sequential, or therapeutic equivalence, the Topstone team will analyze your data using the latest bioinformatics methodologies and the most appropriate statistical tools and techniques to maximize your data’s potential.
Our comprehensive biostatistics services include:
- Protocol Review & Development
- Sample Size Calculations
- Randomization Schedule Preparation
- Statistical Analysis Plan (SAP) Development
- SAS Programming and Independent Validation of Tables, Listings, and Figures
- Interim Analysis Planning
- Topline Analysis Package
- Final Analysis Package
- PK/PD Analysis
- Integrated Summaries of Safety and Efficacy (ISS/ISE)
- Statistical Reports
- Statistical Review of Clinical Study Reports (CSR)
- Submission-Ready Services (SDTM, ADaM)
CDISC Data Conversion Services
Topstone is an active member of the Clinical Data Interchange Standards Consortium (CDISC) and a Registered Solutions Provider. CDISC data standards are now applied to various phases of clinical research and are rapidly becoming industry standard. Since the end of 2016, SDTM, ADaM and Define-XML are the only supported formats for all clinical data submitted to the FDA.
The Topstone data conversion process uses established techniques for converting clinical study data to the CDISC format and the creation of metadata (define.xml) for regulatory submission.
Our comprehensive CDISC data conversion services include:
- SDTM annotated CRFs
- SDTM datasets
- ADaM analysis datasets
- Pooled analysis datasets (ISS/ISE)
- Define.xml metadata and Define.pdf
- CDISC controlled terminology
- Data Handling report
- FDA reviewers’ Guide
- eCTD structure
SDTM, ADaM, and Define.xml Workshops
Topstone offers a range of workshops designed to help organizations understand data conversion requirements and implementation of industry data standards.
We provide workshops on SDTM, ADaM, and define.xml, click here to see upcoming workshop dates.