Clinical Trial Planning
Our services include:
Develop a Regulatory Strategy for Clients
We work closely with clients to develop a tailored regulatory strategy that aligns with their business objectives and ensures compliance with applicable regulations.
Work with Local Regulatory Specialists
We have established relationships with local regulatory specialists in desired markets, including the FDA and CE Mark, to provide clients with expert guidance and support throughout the regulatory process.
Coordinate Meetings with Regulatory Authorities
We coordinate meetings with regulatory authorities, including the FDA and CE Mark, to ensure that our clients’ voices are heard and their concerns are addressed.
Submit Official Requests for Approval
We submit official requests for approval on behalf of our clients, ensuring that all necessary documentation is complete and accurate, and that the submission process is smooth and efficient.
Determining Cohort Size and Demographics; Inclusion and Exclusion Criteria, etc:
Our team will work with you to determine the appropriate cohort size and demographics for your clinical trial, as well as develop inclusion and exclusion criteria to ensure your study is built optimally.
Identifying and Recruiting Clinical Trial Centers and Appropriate Infrastructure:
We will identify and recruit clinical trial centers with the appropriate infrastructure to support your study, including access to patient populations, specialized equipment and expertise.
Identifying and Recruiting Local PIs (Primary Investigators):
We will identify and recruit local PIs with expertise in your study’s therapeutic area and ensure they meet all regulatory requirements.
Establishing Primary and Secondary Endpoints:
Our team will work with you to establish primary and secondary endpoints for your clinical trial, ensuring they are relevant, measurable, and achievable.
Training Local Medical Team (Physicians, Nursing Staff, Technicians, and Clinical Research Coordinators (CRCs):
We will provide comprehensive training to the local medical team, including physicians, nursing staff, technicians, and CRCs, to ensure they are equipped to conduct your clinical trial to the highest standards.
Data Collection and Statistical Analysis:
Our team will collect and analyze the data form your clinical trial, using state-of-the-art methods and tools to ensure the accuracy and integrity of the data.
Copywriting Services
We will provide copywriting services for your clinical trial, including study protocols, informed consent forms, and other relevant documents, to ensure they are clear, concise, and compliant with regulatory requirements.
Determining Cohort Size and Demographics; Inclusion and Exclusion Criteria, etc:
Our team will work with you to determine the appropriate cohort size and demographics for your clinical trial, as well as develop inclusion and exclusion criteria to ensure your study is built optimally.
Identifying and Recruiting Clinical Trial Centers and Appropriate Infrastructure:
We will identify and recruit clinical trial centers with the appropriate infrastructure to support your study, including access to patient populations, specialized equipment and expertise.
Identifying and Recruiting Local PIs (Primary Investigators):
We will identify and recruit local PIs with expertise in your study’s
therapeutic area and ensure they meet all regulatory requirements.
Establishing Primary and Secondary Endpoints:
Our team will work with you to establish primary and secondary endpoints for your clinical trial, ensuring they are relevant, measurable, and achievable.
Training Local Medical Team (Physicians, Nursing Staff, Technicians, and Clinical Research Coordinators (CRCs):
We will provide comprehensive training to the local medical team, including physicians, nursing staff, technicians, and CRCs, to ensure they are equipped to conduct your clinical trial to the highest standards.
Data Collection and Statistical Analysis:
Our team will collect and analyze the data form your clinical trial, using
state-of-the-art methods and tools to ensure the accuracy and integrity of the data.
Copywriting Services
We will provide copywriting services for your clinical trial, including study protocols, informed consent forms, and other relevant documents, to ensure they are clear, concise, and compliant with regulatory requirements.
Determining Cohort Size and Demographics; Inclusion and Exclusion Criteria
Our team will work with you to determine the appropriate cohort size and demographics for your clinical trial as well as develop inclusion and exclusion criteria to ensure your study is built optimally.
Identifying and Recruiting Clinical Trial Centers and Appropriate Infrastructure
We will identify and recruit clinical trial centers with the appropriate infrastructure to support your study including access to patient populations specialized equipment and expertise.
Identifying and Recruiting Local PIs
(Primary Investigators)
We will identify and recruit local PIs with expertise in your study’s therapeutic area and ensure they meet all regulatory requirements.
Establishing Primary and Secondary Endpoints
Our team will work with you to establish primary and secondary endpoints for your clinical trial ensuring they are relevant, measurable, and achievable.
Training Local Medical Team
We will provide comprehensive training to the local medical team, including physicians, nursing staff, technicians, and CRCs, to ensure they are equipped to conduct your clinical trial to the highest standards.
Data Collection and Statistical Analysis
Our team will collect and analyze the data form your clinical trial, using state-of-the-art methods and tools to ensure the accuracy and integrity of the data.
Copywriting Services
We will provide copywriting services for your clinical trial, including study protocols, informed consent forms, and other relevant documents to ensure they are clear concise and compliant with regulatory requirements.
At QuestR&D we are committed to delivering high-quality clinical trial planning an execution services ensuring the success of your study and the safety of your patients. Contact us today to learn more about our services and how we can support your clinical needs.