comprehensive CRO services

pharmtrace provides comprehensive clinical trial services including contracting with sites, suppliers, and other service providers, site management and monitoring, data & image management, pharmacovigilance, statistics, and reporting. In addition, pharmtrace provides support in protocol design, trial site selection and training, the management of safety boards and truth panels, and support for regulatory discussions. All pharmtrace services are guided by a risk-based approach, as laid out in the upcoming revision of the ICH-E6 Good Clinical Practices guideline.

pharmtrace has a global reach and successfully managed trials from single center to multi-center, multi-national clinical trials. pharmtrace services are flexible, from comprehensive trial management to specialized expert support. Therapeutic areas include oncology, cardiovascular diseases, neurology, infection / inflammation, orthopedics, urology, gynecology.

 

trial set-up

pharmtrace trial implementation is guided by 3 principles:

  • availability of the required patient (sub-)population and therapeutic area expertise,
  • compliance with technical imaging requirements, and
  • support of the cross-functional team structure at the sites (clinical department - imaging facility).

Implementation includes support in study site selection and qualification, contracting, submissions to concerned authorities / Ethics Committees, and any further regulatory interactions. pharmtrace legal and regulatory experts are familiar with specific requirements for imaging studies; e.g., if patients are studied and followed in more than one institution and several coordinated contracts are required.

trial operations and data analysis

pharmtrace

  • has a network of CRAs experienced in studies that use imaging as an endpoint,
  • applies a risk-based approach to all study operations, including risk-based monitoring guided by central data review,
  • offers data management based on SDTM and ADaM standards,
  • provides safety management including reporting to the Eudravigilance database, and
  • provides comprehensive statistical analysis services.

Major efforts are directed to ensure efficient communication across the clinical trial multi-disciplinary team and across departmental borders at the study sites. The goal is to facilitate the seamless integration of imaging into the clinical trial, to improve overall trial efficiency, reduce the number of  protocol deviations and to generate robust data to support decision making and regulatory discussions.

reporting

pharmtrace provides study reports according to the ICH E3 guideline and, if wanted, supports sponsors in defending results in discussions and meetings with regulatory authorities.

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our core competence

flexible services & global reach from input into imaging strategy, total study management to image management. We work as you want us to work and will cooperate closely with your in-house teams and/or external providers.

generate "clean data-sets" with low variability that directly address drug development and regulatory questions  by selecting endpoints on the basis of the investigational agent's mechanism of action, the pathophysiology of the disease in question and clinical practice.

expertise in image chain management - intelligent integration of imaging into clinical development plans, integrity of image end-point selection, imaging center qualification & training, image acquisition, storage & handling, blinded reads, evaluations and reporting.