At OAR by Boccardi and Donnelly, we offer a comprehensive range of services designed to support the successful execution of clinical trials while prioritizing the needs of participants and our research partners. These services enable us to foster partnerships with sponsors while prioritizing participant safety and contributing to medical advancements across diverse therapeutic areas.
Individual services, packaged services, and custom packages are available.
Schedule a FREE consultation call with OAR by BD to discuss your specific needs.
Services:
Including but Not Limited to:
Training and Education
Ensure compliance, knowledge, and efficiency in conducting ethical and high-quality research. Possible continuing education credits available.
Curriculum Development and Instructional design
We offer comprehensive curriculum development and instructional design services tailored to the clinical research industry. Our expertise ensures the creation of engaging, evidence-based programs that align with industry standards, preparing learners for success in clinical research roles. Whether for academic institutions or private-sector organizations, we design innovative content and learning strategies to enhance workforce development and career advancement.
Clinical Trial Design and Management
Training on designing robust clinical trials, developing protocols, managing budgets, and mitigating risks. Ideal for teams new to clinical research or looking to optimize trial execution.
Research SEminar Series
A series of seminars for those interested in advancing their expertise in clinical research. This series features topics from study design and data analysis to ethical considerations and guidelines along with operational and technical training.
Customized Training Solutions
- Every research team is unique, with specific challenges, goals, and areas for growth. Our customized training solutions are designed to meet your organization’s precise needs, ensuring your team gains the skills and knowledge required to excel in clinical research.
- Tailored Content: We design training programs based on your team’s experience level, research focus, and regulatory requirements. Whether it’s clinical trial management, data analysis, or regulatory compliance, we create content that addresses your priorities.
- Flexible Formats: Our training can be delivered in various formats, including in-person workshops, live virtual sessions, or self-paced recorded session, to fit your team’s schedule and preferences.
Patient Recruitment and Retention
Maximize patient enrollment and retention rates with our targeted strategies. We can assist in developing effective communication plans, patient engagement tools, and recruitment campaigns that resonate with potential participants.
Data Management Services
Clinical research data management services focus on ensuring the accuracy, security, and integrity of data collected during clinical trials. Transform data management with our comprehensive data management services from design, database development, data review, and electronic case report form (eCRF) creation. Ongoing support available to assist with any needs.
Ensure your data is meticulously collected, managed, and analyzed. Our team can help implement robust data management systems to maintain data integrity and confidentiality, meeting all regulatory standards and ensuring reliable results.
ecrf Design
Development of customized databases tailored to the study protocol. Accurately capture all necessary data points while being user-friendly and compliant with regulatory standards.
data Review and Locking
A continuous process where collected data is regularly examined for accuracy, consistency, and completeness. Management of database locking processes to ensure finality before analysis.
Case report form Creation
Use high quality source documents to assure protocol compliance, minimize protocol deviations, and streamline data capture.
Database Development
Ensuring that all trial data is collected, stored, and managed in a secure accurate, and efficient manner. This process involves creating a tailored system that aligns with the study protocol, regulatory requirements, and the needs of the sponsor. The database is easily accessible for analysis and supports the overall study objectives.
Study Design and Data Analysis
A well-structured study is essential for the success of a clinical trial. We can assist you in selecting the right design approach and offer insights on study design to ensure you achieve meaningful clinical outcomes.
Monitoring and Reporting
Maintain oversight of your clinical trial with our monitoring and reporting services. We provide regular updates, detailed reports, and ensure all trial activities are conducted in compliance with the protocol and regulatory requirements.
Turning a Grant Proposal into an IRB Approved Protocol
The protocol requires slightly different information and more detail regarding study design than grant proposals. Allow us to convert your grant proposal into a well-crafted protocol.
Regulatory Submissions and Medical Writing
Let us handle the preparation of regulatory documents, ensuring they fulfill all necessary criteria.
Protocol Optimization
Before you submit, let us review your protocol. We can fine-tune it to ensure optimal patient and site compliance while maximizing efficiency.
Vendor Selection
Let us assist you in choosing vendors that offer the best quality services within your budget while also meeting regulatory standards.
Process Improvement in Clinical Research
We can help identify areas for potential improvement within your existing organizational structure, suggesting changes that can boost productivity and compliance.
Quality Assurance
Uphold high standards throughout the trial process and receive support in preparing for regulatory inspections, ensuring that your organization adheres to all regulatory requirements during the trial.
Study Start-UP
Facilitation of communication with the IRB including submissions, reviews and revisions, contract negotiations with sites, and regulatory management of the Trial Master File (TMF).
Site Management
Site selection, negotiations, and monitoring maintaining clinical research oversite at a site level. Creating study specific training for site staff.
Project Management
Full-service project management from experts in the field tailored to your research needs. Frequent meetings to discuss trial's progress and status.
Risk Assessment and Strategic Planning
We can proactively create strategic plans to mitigate potential risks.
Biostatistics
Leverage the power of biostatistics to draw meaningful conclusions from your data. Our biostatisticians can assist in the design, analysis, and interpretation of clinical trial data to ensure robust and valid results.
Ethical Compliance
Adhere to the highest ethical standards in clinical research. We provide guidance on ethical considerations, informed consent processes, and ensure all activities are conducted with the utmost integrity.
MOre
We are here to help however is needed. Contact Us to arrange generation of a Custom Quote.