pharmtrace provides all clinical services in accordance with the actual ICH-GCP guidelines, the respective study protocol, and any applicable local law.

Study design and regulatory support. Support in designing the clinical trial including primary and secondary efficacy parameters, definition of study populations based on study drug's potential, optimization of study procedures for facilitation of recruitment and minimization of drop-outs, identification of appropriate imaging / biomarker methodology and endpoints. Production of the Study Protocol, CRF design, translation of all essential documents (including patient information, informed consent, protocol summary) in the required languages, submission of all required files to national regulatory bodies and ethics committees; including a "study package test" for internal consistency and completeness before submission.

Trial site selection and qualification. Identification of investigators, assessment of the recruitment potential based on the study-specific requirements. Qualification, training and standardization of study centers (equipment, personnel, image acquisition, manipulation and storage).

Project Management. A project manager is appointed and a project team established for all projects.  All project managers are graduates and have broad experience in managing clinical trials and are the primary contact for all project related issues.  Project management includes the responsibility for maintenance of the Trial Master File, regular updates of the sponsor on the study status, and the coordination of all required activities (monitoring, database set‐up, data entry, query procedures, data cleaning, blinded read activities, statistics, reporting).  Comprehensive SOPs are in place for all associated activities.

Monitoring. Site initiation, interim monitoring, close-out including source data verification and study drug accountability. Monitoring is performed by in-house monitors and pharmtrace's European network of carefully selected freelance CRAs. All CRAs are trained for all relevant aspects of GCP. All monitoring documents are generated from the central pharmtrace project database which guarantees uniform standards and consistent documents for all trial-related activities.

Data Management. CRF creation, data entry using paper CRFs and double data entry or electronic data capture (eCRFs). Data dictionary following CDISC standards, programming of plausibility checks, query management, data cleaning, data transfer.

Imaging, Image Management and Blinded Read. Comprehensive support regarding all aspects of diagnostic imaging including nuclear medicine (e.g., standardization, training, PET tracer logistics). Continuous imaging centre and image quality assurance during the trial, image handling (image warehouse) and database construction, reader qualification and training including truth panel management, image read-out incl. design and conduct of blinded analyses, evaluation and reporting. Interim reads together with the associated statistical analysis, analysis and interpretation of imaging results in the context of the development program.

Statistics and Reporting. Comprehensive statistical support, preparation of statistical analysis plan, data analysis in SAS, reporting, preparation of the clinical study report including appendices.