FIM Heidelberg offers a comprehensive study service:
Project management:
ethical and regulatory consulting
feasibility and risk assessment of study plans, cost calculation, and budget supervision
continuous supervision of milestones
preparation and review of essential study documents (e.g., study protocol, patient's information, and informed consent)
Investigational Medicinal Product Dossier (IMPD)
ethical and authority contacts within the scope of the preparation and submission of documents
contract form and liquidation
insurance of study participants
development and implementation of recruitment strategies
quality assurance, organization of meetings and communication structures (involving study centers, labs and manufacturer of test preparations), logistics of study material and study medication, support in audits and inspections
Clinical monitoring: Assurance of the study protocol and ICH-GCP compliance by regular site visits, source data validation and service of the essential documents for studies, including drug accountability and investigator study file (ISF)
Data management: Preparation and review of Case Report Forms (CRF), data management plan, construction and validation of study databases, also as a RDE solution, control of further inquiries (queries), encoding of data, e.g. use of MedDRA or ICD-10; coordination of data flow and electronic supervision of data management (Audit Trail), randomization lists, (graphic) processing of study results for reports, presentations, and study meetings
Biometry and data analysis: Biometrical study planning (study design, population, terminator points, case number planning); concept of the biometrical part of the study protocol, preparation of the statistical analysis plan (SAP), planning and realization of evaluations (incl. interim analyses, case number adaptations, statistical report), pharmacokinetic analyses with validated software, supporting the interpretation of the study results; cooperation in preparing the final report
Pharmacovigilance: Current and entire capture of events (incl. SAE, SUSAR), assessment, control of events and reporting to health authorities, sponsor, and ethical committees according to the legal obligations and timelines, development safety update report (DSUR)
Clinical conduct with documentation of important endpoints (e.g. biomarker, surrogates, extensive possibilities of medical imaging): recruitment of study participants, screening and final examinations, execution of clinical studies under intensive care monitoring, (pre-analytical) standardization of sample preparation, and data collection
Accompanying laboratory research: extensive, fully equipped laboratory and scientific competence to carry out accompanying translational molecular and cell-biological laboratory research
