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Radiation Oncology Clinical Trials

ACR® offers a full suite of services to design, conduct, monitor and analyze oncology clinical trials in a GCP compliant environment. Projects can be for a defined subset of activities, such as radiation therapy quality assurance, or encompass the entirety of a clinical trial life cycle.

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Clinical Trials Administration

Budget development and administration.
Contracts management and industry relations .
Site membership application and contract processing.
Study management — sites, vendors, study team.
Collection of essential documents and eTMF management for health authority application intent studies.
Coordinates the development of study plans, e.g., communications plan, steering committee charter.
Website management, media relations, publicity.
Translational research and biobanking activities coordination.
Publications review — abstracts, manuscripts, presentations.

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Protocol Development and Regulatory Compliance

Concept, protocol and ICF development, review, submission to regulatory authorities, and maintenance.
Investigational drug distribution implementation.
Maintenance of OHRP assurances, the IRB database and other regulatory collections.
Preparation of protocol and safety information for distribution to participating sites.
International member regulatory support.
Preparing and implementation of monitoring plans; conduct of monitoring visits.

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Statistics

Collaborates with physician researchers in the development, monitoring and analysis of study protocols.
Develops and implements appropriate study designs for protocols.
Ensures that protocol requirements are clearly stated and appropriate for the study design.
Develops and implements trial randomization schemas/algorithms.
Performs statistical analyses for semiannual and interim monitoring requirements and all endpoint reporting and publications.
Collaborates with investigators on translational and outcomes research projects.
Researches and implements new statistical methods as needed for study design or analysis.
Develops the study statistical analysis plan.

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Data Management

Assists the study team in the development of CRFs including web-based set-up and logic in our Research Management System (RMS) and Medidata Rave.
Supports clinical data collection for patients entered on trials including data validation and query generation, and adverse event (AE) reporting.
Conducts training for site CRAs and study chairs.
Coordinates study chair reviews.
Develops study data management plan.

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Radiation Therapy QA and Core Laboratory

Develops and implements study-specific credentialing and monitoring procedures as required for study modality(ies) .
Collaborates with RT credentialing partner to ensure all sites are qualified for participation in specified study.
Reviews RT specifications in developing protocols.
Develops and implements procedures for RT QA including conducting initial of RT prescription data and facilitating the final study chair review of treatment data.
Facilities study chair reviews of RT treatment data.
Collaborates with medical physicists and radiation oncologists to ensure uniformity in QA for advanced technology trials.
Provides educational opportunities for CRAs and investigators.

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Why Should You

Choose Us?

Collaboration

Our relations with RTOG Foundation and the Foundation’s long-standing relationships with its affiliated sites, partners and vendors allows us to quickly mount and complete a wide range of study-related activities. RTOG investigators at ACR provide scientific leadership, education and advocacy.

Infrastructure

Our radiation oncology team is stable and experienced with access to state-of-the-art infrastructure, such as Medidata Rave®, an industry standard eCRF platform. We also have access to TRIAD, an image collection platform familiar to thousands of U.S. and former U.S. sites.

Expertise

Our team has long-established contracts with consultants for advanced clinical trial services including the most well-known system of Radiation Research QA in the world and have successfully completed multiple vendor audits.