Data management is essential in clinical development and it influences the quality of data received from investigative sites.

We will assist in:

• Subject Case Record Form management
• Data validation and review
• Data clarification forms (DCF’s)
• Edit checks and data queries
• Electronic data processing/reconciliation
• Data migration

Bio-Statistics:

Our biostatisticians have a desire for quality and implement the best approach to a client situation/scenario to ensure correct analysis without an over complex process. By using the appropriate tools, we are able to demonstrate the efficacy of a drug and present the results in the clearest way possible. We pride ourselves on our expertise and the ability to show clear results of bio statistical services in to our customers. We also take a personalised approach dependent on our clients needs which forms lasting partnerships and enables our experts to transfer their biostatistics knowledge on to our customers.

Clinical Study Report 

Clinical Study Reports (CSRs) are often created as part of the process of submitting applications for new medical treatments to regulators.

The content of CSRs is detailed in the ICH guideline E3. A clinical study report provides a clinical and statistical description, presentations and analyses of the completed study. The clinical study report should include an explanation of the critical design features, the plan, methods and conduct of the study, individual patient data and details of analytical methods.