Clinical Data Sciences
Our expert team at WriteSource Medical can help you with an array of clinical data science services. We can provide:
- Full-service capability: support of your clinical development program, including full project management from protocol to manuscript.
- Tailored task-based solutions: working within the study team providing specific expertise and support of contracted tasks.
Need a database but not sure where to start?
Good database design is key to successful clinical trial implementation, analysis and reporting. Good design supports the key data quality dimensions of accuracy, completeness, consistency and integrity.
Quality database design:
- improves accuracy and timely data capture
- ensures relevant data capture to answer the clinical question
- reduces manual review, promoting data consistency and integrity
- improves the relationship with your sites and statistician!
- generates a quality analysis output and report
WSM can build your database and perform all data management tasks or support your team through review of key documentation and design considerations.
Want to get your protocol right the first time?
Wouldn’t that be amazing?
So we might not be able to prevent protocol amendments, but our data management team can:
- highlight protocol inconsistencies
- generate questions on study design
- check consistency between synopsis, time and events schedule and protocol procedures
- ensure all relevant data to answer your clinical question has been captured
highlight areas of potential site confusion
Preventing problems at the protocol stage can save a lot of time and money down the track.
Having problems with data entry?
Site interpretation of data capture requirements can be variable. We can perform data issue trend analysis to identify areas of risk and propose tailored strategies for mitigation.
Do you need another pair of eyes on your statistical output?
Our data management team can review your Tables, Figures and Listings (TFLs) documents.
WSM can ensure that data produced are complete, relevant to the study objectives, consistent with the protocol, are clear; and provide document quality control reviews.
Create and implement quality clinical data management systems compliant with regulatory guidelines and standards.
Validation based on data quality dimensions of accuracy, consistency, completeness, and integrity.
Support to implement CDISC model structure.
Provide issue trend analysis including tailored mitigation strategies.
Data driven review of clinical trial documentation and/or generation of data processes.
Best practice, hints and tips informed by industry experts.