Quality & Expertise
Both the internal staff and the selected partners have an unrivaled extensive experience in Biostatistics, Clinical Data Management and Medical Writing services all acquired serving for a long time in pharmaceutical companies or/and Contract Research Organizations. The staff has a documented international experience in managing studies and submissions, also for FDA and EMA. Our standard operating procedures and a well trained staff guarantee our clients with services compliant with the most rigorous regulatory standards. Quality control processes also include senior-level review throughout each stage of the project.
We work cloasely with our clients through a team approach under the supervision of a senior biostatistician who is well experienced in data management ensuring all tasks of data management, biostatistics and medical writing are conducted in adherence to timelines, requirements, and quality standards expected from the client. As soon as the project starts a senior biostatistician and a medical writer design the trial, write the study protocol and with the support of a data manager create the case report form working closely with the client. After the study protocol and the CRF are finalized, the data manager designs the database, the entry screens, and develops edit checks to identify any discrepancies in the collected data. The lead biostatistician writes the statistical analysis plan comprehensive of the layout of the tables, listings and figures. Once in house, CRFs are entered into the database and cleaned. In the meantime a biostatistician creates and tests SAS programs for the foreseen analysis. In brief, the statistical analysis or the integrated clinical statistical study report can be released rapidly after the database lock.
Whether you provide in house standard operating procedures and formats we guarantee the maximum flexibility to meet your needs. We don’t cage your clinical trial into our standard operating procedures, processes or inappropriate software. Instead, we choose the best approach, the best processes and the appropriate software to provide you tailored high quality cost-effective solutions compliant with the regulatory standards in an efficient and timely manner.