Interventional Studies

We know that the success of a study project is based on the combination of quality and swift implementation throughout study planning, initiation and conduction.

Competently advised contract implementation between sponsor and study site as well as efficient submissions to ethics committees and competent authorities are essential success factors for a rapid study start. Prompt processing of application documents, timely annual renewal of ethics committee approvals and prompt settlement of all necessary filings throughout the entire study period are a matter of course to us.

The team of S2 ScienceSolutions offers the following services – either as a package solution or individual service – for interventional and non-interventional studies. As a full-service CRO we are pleased to support commercial as well as academic projects (Investigator Initiated Trials, IITs):

• Synopsis and protocol development including statistics and patient information
• IMPD preparation
• CRF development and data management
• Feasibility and site selection >>>
• Study- / Project management >>>
• Submissions to ethics committees and competent authorities
• Monitoring & site management: initiation, monitoring and close-out visits
• Co-monitorings
• Training to site and sponsor staff >>>
• Quality assessments >>>

Non-Interventional Studies (NIS)

Within the context of post-marketing surveillance and risk management non-interventional studies (NIS) gain more and more in importance.

Whether to elucidate further safety profiles or to evaluate product usage in daily practice: non-interventional studies are the method of choice for the generation of “real world evidence”. Results obtained from NIS have major impact on product authorisations and the product life cycle – thus study conduct on a high quality level becomes a critical factor.

The team of S2 ScienceSolutions offers the following services – either as a package solution or individual service – for non-interventional studies. We are pleased to support commercial and academic projects likewise in this sector as well.

• Protocol development, statistics & patient information
• CRF/e-CRF development
• Site selection
• Study-/Projectmanagement
• Submissions to ethics committees & competent authorities
• Monitoring & site management: initiation, monitoring and close-out visits
• Safety Services >>>
• Data management & data analysis
• Study reports & preparation for publication >>>

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