Data Management & Biostatistics
Trusted quality and passion.
We deliver the tailored solutions you need to bring treatments to patients faster.
Reliable data, quality solutions
Generating accurate data is only the beginning. TFS HealthScience provides you with the right tools and people to capture, analyze, and display the information in appropriate formats. By working with reliable sources, robust procedures, and proven experts you are getting the results you can trust, on-time and on-budget.
One project, one team
Whether it’s our Data Management or Biostatistics team, we can describe them in one word: proficient. They are talented, experienced, and used to working with challenging timelines and tight deadlines. You can count on quality outcomes at every stage of your project. The numbers speak for themselves:
- Our data management team met 98% key performance indicators (KPIs) with all customers
- Our biostatistics average “milestones met in full” with all customers is 99%
The teams are based across Europe and the US, ready to join your project in the most convenient location.
Shaping solutions to your needs
Our preferred EDC systems and tools, chosen for their flexibility and capacity to adapt to almost any kind of project include Medidata Rave, TrialMaster, and Trial Online. Customers are able to leverage our internal solutions for ePRO, patient retention, and eConsent through our preferred vendor relationships. It’s all about agility and accuracy.
Medidata Rave
TrialMaster from OmniComm
(an Anju Software Company)
Trial Online
from Replior EDCs
Data Management Services
Full-service data management support:
- Data management essential documentation (Data Management Plan, Data Validation Plan, Data Transfer Specifications, Data Cleaning Plan, etc.)
- eCRF design database set-up using our preferred EDC systems, including edit checks programming
- Validation of the electronic tool used during the study by including UAT lead
- ePRO/eDiary set-up, validation, and documentation
- Vendor management
- Integration of external data (laboratory, IRT systems, images, ePRO/eCOA, wearables, etc.)
- Training of investigators, site personnel, monitors, and other team members
- Helpdesk and user management
- Ongoing data cleaning, import, and reconciliation of external data
- Programming of standard and customized data management outputs (Data Review Listings (DRL), patient profiles, protocol deviations, clean patient tracker)
- Reporting (study status reporting, standard reports, ad-hoc reports)
- Ongoing medical coding using MedDRA, WHO DD, and ATC dictionaries
- SAE reconciliation support
- Management of database closure process
- Archiving
Other data management services:
- Efficient management of protocol deviations through our unique tools
- Event adjudication
- eConsent configuration
- Patient retention tool configuration
- System validation
Successful partnerships
TFS selects the best EDC technology based on the study’s requirements. Our customers benefit from our preferred EDC partnerships (Medidata Rave, TrialMaster, Trial Online) or from the experience of our team using other EDC systems.
Medidata Rave
Medidata Rave is TFS’ preferred EDC system based on its demonstrated ability to streamline the data management process. Certification for the use of Medidata Rave, obtained in 2019, added to our efficiency by elimitating many of the manual steps in the process and improving the delivery time, decision-making process, and real-time inspection readiness.
How TFS and Medidata can support your project:
- TFS certified for the use of version Medidata Rave EDC 2019.1.1
- 6 Database Programmers
- 14 Clinical Data Managers across all hubs
- Rave RTSM: randomization and trial supply management system completely integrated
- Use of Rave Coder in our trials
- Use of Global Library functionality and TFS CDASH library
- Other Medidata products integrated in the EDC: Rave eCOA for managing ePRO and investigator assessments, Rave eConsent, and more
TrialMaster™
We developed a long-standing strategic partnership with OmniComm Systems (an Anju Software company), a leader in eClinical solutions. TrialMaster™ enables us to address unique clinical trial needs through their flexible functionality.
How TFS and TrialMaster™ can support your project:
Flexible functionality
- Flexible design: custom roles, visit flow, dynamic forms
- Multiple options for external data integration (IRT, ePRO, Lab, images, ECG, etc) ind real-time mode, sftp or manual import
- Interactive real-time reports for tracking and backlog purposes (standard reports and ad-hoc reporting tool)
- Lab ranges management (central lab and local)
- Autoencoder (MedDRA, WHO DD, supporting the change of version)
- Event adjudication
- Alerts and Notifications (SAE, the inclusion of patients, etc)
- Protocol Deviation Management
Tried and tested
- Used since 2000 on the global market for phase I-IV studies, NIS and RWE, and investigator-initiated studies
- 30+ active studies ongoing in TrialMaster
- 20 CDMs fully trained on TrialMaster, including 8 people capable of programming the eCRF
- Standard CDASH library in TrialBuilder
- Long-term relationship with OmniComm and the technical support team (EU & US) established before 2000
Compliant and secure
- Hosted solution (data centers & nightly backup)
- Compliant with 21 CFR Part 11 Standards
- GDPR compliant
- Role-based security (a standard set of roles that can be modified)
Trial Online
Used globally in all phases and indications, Trial Online EDC is easy to use and cost-effective. Fully compliant with industry and regulatory standards, it’s suitable for non-interventional and investigator-initiated studies.
How TFS and Trial Online can support your project:
Proven in the field
- Long-term partnership with TFS
- Used since 2000 on the global market, Phase I-NIS
- 30+ active studies ongoing in Trial Online
- Easy and quick set-up and change request handling
- Standard CDASH library in Trial Online
Effective and self-explanitory
- ePRO tool integrated into the system (web and app)
- eConsent tool integrated into the system
- Patient retention app integrated into the system
- Virtual Visits module integrated into the system
- Quick eCRF set-up
- Role-based to-do lists
- Configurable, standard, and custom reports
- Integrated Auto-encoder and eLearning module
Compliant and secure
- Hosted solution (EU)
- Compliant with 21 CFR Part 11
- GDPR compliant
- Role-based security (a standard set of roles that can be modified)
Transparency at every stage
Getting your product to market is a multi-faceted process. Part of our role is to make it as straightforward as possible. We do this by outlining each stage in detail so that you know where you are and what to expect. We build trust based on communication and transparency.
Data management process flow
- CRF design reviewed, approved, and signed by CDM, BIS, PM, and customer
- Database set-up including eEdit checks and UAT performed
- ePRO/eDiary set-up, including validation and documentation
- Set-up of external data integration (Lab, IWRS, images)
- System training begins (eLearning, investigator meeting, eCRF)
- Ongoing data review and query management
- Ad-hoc and status reporting (listings, metrics, etc)
- AE, concurrent diseases, and Con Med coding (MedDRA, WHO)
- Data transfers (Lab, IWRS, Images)
- Vendor management
- Ongoing coding
- Ongoing reporting and review of protocol deviations
- Ongoing SAE reconciliation
- 24/7 helpdesk available
- Final data cleaning and coding
- Final vendor/query reconciliation
- SAE reconciliation – final with approval
- Final QC completed
- Archival of database and supporting documentation
Expert biostatistical support
TFS biostatisticians create the foundation of the study design contributing to the whole process, including niche adaptive trials, pragmatic trials (e.g., real-world evidence), and sample size simulations. Given the responsibility their work carries we understand the value of continuity, reliability, and experience. With that in mind, we are proud to say that the average time our statisticians have been working at TFS is 10.5 years. When we partner on your project, that knowledge becomes a part of your team.
Biostatistics and programming group services
- Support for preliminary meetings with regulatory authorities
- Input to study design
- Protocol review and/or writing of statistical sections of the CSP
- Sample size and power calculations and/or simulations
- Randomization services
- Statistical analysis plan development
- Interim analysis for various adaptive designs (blinded or unblinded)
- Programming of tables, figures and listings (TFLs) shells
- CDISC mapping (SDTM, ADaM) and related documentation (define.XML, Reviewer’s Guide)
- Independent statistical and programming support for DMCs, DSMBs, and IDCs
- Programming of TFLs
- Dry-run TFLs (before DBL) generation
- Participation in pre-DBL meeting / Blind Data Review Meeting
- Topline results delivery (5 working days after DBL)
- Final validated TFLs delivery
- Statistical input to CSR, publications, and assistance in answering editor comments
- Preparation of integrated summaries of safety and efficacy (ISS/ISE) for regulatory submissions to the FDA and EMA
TFS Data Management and Biostatistics has the global reach, experience, technologies, and dedication to quality and customer service to benefit your next project.