BEST DATA AND ANALYSIS SERVICES
The way you establish, collect, manage, interpret and prepare clinical trial data for submission can be the difference between a successful trial and an expensive failure. Clindataceutics’s industry-leading team of data management professionals and statisticians is one of the largest in the industry. With real-world experience in adaptive trial designs and the latest data analytics platforms and technologies, we make certain you can not only access, but also examine data at an individual patient level.
Using Insight — our powerful clinical trial management system — you gain access to a real-time snapshot of your trial status at any time When your trial is complete, Clindataceutics’ steam extracts, analyzes and interprets your data, then prepares it for presentation to regulatory agencies and the rest of the world. At the end of the day, our job is to help ensure your entire project team is able to conduct compliant, cost-effective trials. We focus on the intricate details of your study so you can focus on your trial and on providing new therapies to patients around the world.
CLINICAL DATA MANAGEMENT
At Clindataceutics we believe in providing high quality clinical data management to support your drug development needs to get drugs to market as quickly as possible so patients have access to drugs. We provide bespoke solutions tailored to your requirements and provide real time, faster access to data meaning faster decisions can be made to keep patients as safe as possible.
As a niche data-focused CRO, our expertise allows us to focus solely on the data of a clinical trial and enables us to develop trust with long lasting partnerships. By concentrating exclusively on data we are able to offer efficient and flexible clinical data management solutions, we are seen as a niche provider for smaller teams or a valuable experienced partner for larger accounts.
Clindataceutics provides end to end comprehensive clinical data management solutions from Phase I through to post-marketing trials. Our team of global clinical data management experts are committed to upholding a standardized, process-driven approach.
OUR CLINICAL DATA MANAGEMENT SERVICES INCLUDE:
- On-shore and off-shore Clinical Data Management Services
- EDC and Paper Trial Set-Up & Management
- Certified Medidata RAVE Builders
- Access to other EDC solutions (Low Cost, Oracle etc.)
- Data Management Plan (DMP) development
- Data Management Project Management
- CRF/eCRF design and development
- CRF Annotation & Review
- Database Build & Design
- Data validation specifications
- Edit checks Programming & Testing
- Data processing through double data entry
- Query Management
- Medical Coding
- Safety Data Management & Reconciliation
- Data Export/Transfer
- CDASH Compliant deliverables
- Real-time data viewing and reporting
BIOSTATISTICS AND STATISTICAL PROGRAMMING
Clindataceutics’s biostatistics and statistical programming team provides operational and strategic statistics for clinical research and development. Our operational expertise allows us to deliver the high-quality statistical output required for every aspect of drug development including the statistical material you need for study reports and for regulatory responses.
- Pre-Clinical Studies – we provide support and advice for pre-clinical studies to ensure the study objective is being fulfilled.
- Protocol Input – our input includes clinical study design, sample size calculations and consultancy advice during the start up of a study.
- Randomization/Unblinding – we offer production of randomizations including production of emergency unblinding envelopes.
- Statistical Analysis Plan (SAP) and Output Shells – we optimize the use of our Consultant Statisticians to ensure innovative approaches to the statistical content of a study to increase the chances of a successful trial.
- Clinical Data Interchange Standards Consortium (CDISC) – using CDISC standards ensures that the data used in the outputs produced complies with regulatory standards.
- Output Production – using Clindataceutics standard macros within the SAS ® Programming system ensures increased efficiency when producing outputs.
- PK/PD Analysis – modeling the relationship between exposure and response using nonliner models and non-linear mixed effect modeling.
- Production of Statistical Report/Clinical Study Report – our statistical and medical writing teams collaborate to produce high quality reports.
- Interim Analysis/Data Safety Monitoring Boards (DSMBs) – we offer unblinded statistical support and advice for Interim Analyses and DSMBs.
- Meta Analysis – our expert statisticians can advise on potentials for bias during a Meta Analysis as well as on statistical methods to use.
- ISS/ISE – we provide support for the integration of safety and efficacy data prior to regulatory approval.