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Our Business Development team expertly navigates the complex university systems, as well as relationships with businesses, funders, and industry partners to prepare compelling pitches and proposals. In addition, our team strategically assesses the funding landscape, potential partners, and funding mechanisms to optimize research funding opportunities. Our team works with stakeholders to identify clinical sites as well as to coordinate budget and proposal development to ensure accurate and timely submissions.

Program Management
Our program managers excel at navigating 黑料网鈥檚 vast network of resources, sites, sponsor research operations, and administrative processes to integrate complex study procedures while meeting milestones and producing quality data and results.

Trial Operations and Site Monitoring
Our team trains and provides support for clinical site staff, facilitates communication, develops and implements recruitment and retention strategies, and incorporates protocol amendments. We also work with biorepositories, labs, and imaging reading centers to ensure protocol compliance and quality assurance. Site monitors conduct site initiation, intermittent monitoring, and trial close-out visits to ensure compliance with protocol, participant safety, and data quality.

Clinical Coordination

Our team works with sponsor, network, and trial leadership to plan scheduling and logistics for virtual and in-person meetings, facilitate communication, provide documentation, keep records, and support manuscript development and tracking.

Data Operations and Analytics

Within the CRA and through our established partnerships, we offer 21 CFR Part 11 compliant data capture, accrual tracking, trial master file data management, clinical data, and program management systems and support. Our team of data management experts develop case report forms and create site performance reports and dashboards, as well as reports for sponsors and network leadership.

Medical Affairs

The CRA鈥檚 Medical Affairs team designs protocols, interprets data, and communicates with stakeholders to ensure the scientific integrity and strategic alignment of clinical trials.

IDS

The CRA partners with proven Investigational Drug Services (IDS) entities to manage the formulation, labeling, packaging, and dispensing of investigational drugs and placebos used in clinical trials. We ensure compliance with regulatory standards and protocols, including inventory tracking, shipping, storage, and dispensing.

We have dedicated personnel to coordinate agreements across institutional offices and push legal documents over the finish line. Our services include the development, review, and negotiation of master services, clinical trial, data use, material transfer, data confidentiality agreements, and all supporting documents in collaboration with 黑料网 procurement offices and the .

The CRA has dedicated resources from the 黑料网 SOM Finance & Research Support Team (FiRST) to provide comprehensive financial services from strategy to execution. This includes managing budgets, establishing site subagreements, ensuring compliance with financial regulations, and optimizing financial processes for large-scale clinical trials that often involve multiple funding sources, intricate financial reporting requirements, and the need for strategic financial planning.

The CRA Regulatory team assists in providing strategic guidance for FDA and sIRB submissions, including coordinating initial submissions and reliance agreements, and providing ongoing support to ensure compliance through the life of the protocol.

Our Scientific Writing group and operations staff assist with the development of grant proposals, trial protocols, manuals of operations, investigator’s brochures, recruitment materials, and other documentation. Additionally, we provide support for dissemination of findings through abstracts and manuscripts.

The CRA has dedicated technology specialists who have expertise in clinical trial apps, management software, and reporting dashboards used by both academia and industry. Our team provides documentation and training to sites and other users and is available for direct support.