Main tasks of the IELSG are the development and the conduction of biological and clinical studies to improve our knowledge and identify new treatments and ways to cure lymphomas. To carry out these activities, the IELSG works closely with the investigators of the many institutes that have become part of its network.
The IELSG Operating Office provides expertise in several areas of clinical trial development and conduction, in compliance with ICH/GCP and the different national regulations, policies and procedures.
The Office covers all operational aspects for the implementation of multicenter clinical trials from study start-up through database lock including the revision of all documents provided for the trials.
In particular, it supports the investigators in a variety of crucial aspects for the clinical conduction of the studies, including trial designing, sample size calculation, protocol writing, regulatory affairs, data management and site monitoring, drug safety, preparation of final study datasets, statistical analysis and study reports.
The Office is responsible for administrative management, covering budget preparation, invoicing and payments and of the legal agreements with the study sites, the pharmaceutical companies and the CROs (Contract Research Organizations).
A Quality Assurance Team ensures that clinical trials are conducted, documented and reported in compliance with good clinical practice (GCP).
