SERVICES

Maestro is an interdisciplinary organization that works seamlessly and flexibly with Study Sponsors to provide a liaison to the leadership at Chinese clinical centers of excellence.

We also provide a “one-stop service” for both participating CCTC institutions and for study sponsors that precisely fits the needs of both — greatly accelerating clinical trials while assuring the highest ICH/GCP quality standards.

• Evaluation of study feasibility in the local region involving Maestro physicians, clin-op managers, regulatory directors, and CCTC PIs.
• Facilitate integration of CCTC institutions as sites into larger global studies already underway or under development.
• Overall study project management, including development of an overall timeline and study budget based on regulatory, drug supply, enrollment, and clinical operations parameters.
• Provision of professionally trained and supervised Clinical Research Coordinators who are integrated into each CCTC site to directly support the local trial execution effort and ensure full protocol compliance and data integrity.
• Management of regulatory interactions at the Chinese SFDA and local/institutional levels to accelerate IND approvals and optimize timeline management.
• Provision of regional medical monitoring (bilingual physicians familiar with local medication brand names, standard of practice, etc.) that seamlessly interacts with Sponsor medical monitor/clinical study leaders.
• Clinical operations management to seamlessly interact with Sponsor clinical study staff.
• All language translations written and spoken, and training for study sites
• Organization and conduct of investigator meetings.
• Core Pharmacogenomics Laboratory. Maestro is establishing state-of-the-art facilities that represent collaboration between leading Chinese and Western institutions that are also CLIA compliant. These facilities, located in each of its key institutions’ cities, will offer premium services involving the handling of tissue and serum specimens for analysis of biomarkers, gene expression profiling, mutation and gene silencing studies, etc. These ancillary analytical functions will become increasingly prevalent as both study sponsors and regulatory bodies are recognizing the need to include these data both in the commercial and regulatory evaluation of new anti-cancer regimens.
• Study Site Management
  • Pre-identification and qualification of Maestro study sites with top-tier KOLs as members of the CCTC.
  • Centralized negotiation of contracting to greatly expedite the completion of contracting and initiation of study activities. This function particularly helps reduce typical bureaucratic challenges and delays as a result of our understanding of rules/regulations, local business and social cultures, negotiations, personal working relationships, etc.
  • State-of-the-art electronic data capture (EDC) system, customized to support the establishment of ICH-GCP practice at sites in the CCTC, with primary source documentation captured and electronically linked to CRFs. Also can adopt sponsors existing EDC systems.
  • Ensuring adequate GCP training for all study personnel at all study sites.
  • Provision of experienced and well-trained study coordinators to study sites; study coordinators are employees of Maestro.