From the inception of your project to final reporting, statistical consultancy is key to ensuring the design of your study is fit for purpose, meeting all your clinical objectives. Our team of statisticians, consultants and SAS programmers offer you a breadth of industry experience across a wide range of therapeutic areas and trial designs as well as extensive experience of interactions with regulatory agencies, supporting both development planning strategies and expediting the approval process.
Working with you, they will advise on the most appropriate study design and prepare detailed, comprehensible and accurate Statistical Analysis Plans to ensure successful evaluation and reporting activities. The team will convert the plan into reality from quality programming of datasets though to outputs and reports.
We can also offer a consultative approach to adaptive clinical trial design methodologies providing greater flexibility as well as time and cost savings. Statistical representatives can be assigned to any Data Safety Monitoring Board and/or Steering Committee used in your study. Our statisticians can also assist you with interpretation of study results.
Our team of dedicated statistical programmers provide a high quality service in the development of all study data presentations employing internal or client standards. We also offer CDISC compliant delivery including data mapping/integration of multiple studies and legacy data to meet current regulatory reporting guidelines, as well as the creation of defines, reviewer’s guides and annotated CRFs.
Our teams can support and guide you in many areas, including:
SQN has the experience of dealing with regulatory agencies to agree ISS/ISE strategy, and the flexibility to deal with client’s unique requirements for complex situations. We can provide expertise in dealing with the specific issues that an ISS/ISE can bring and appreciate the differences in the planning and conduct these projects compared to single studies based on our extensive experience.
We will work with you to understand your requirements, offer guidance, assess the individual studies. We will work with you to create the ISS/ISE plan, merge the required data and deliver the resulting analysis on time.