Strategic Clinical Development Planning
Understanding the business needs of an organization is critical to development of an effective clinical development program. We will partner with your organization's R&D, Medical Affairs and Marketing organizations to arrive at a cost effective clinical development program that meets company objectives.
Understanding the business needs of an organization is critical to development of an effective clinical development program. We will partner with your organization's R&D, Medical Affairs and Marketing organizations to arrive at a cost effective clinical development program that meets company objectives.
Study Protocol Development
Gregory Biancone Consulting has years of experience in creating protocols that address the needs of sponsors. Our experience spans the drug development spectrum from concept through commercialization. In addition, we will ensure that your study will be scientifically rigorous and compliant with the requirements of the applicable jurisdictions (US FDA, Health Canada, and EMEA).
Gregory Biancone Consulting has years of experience in creating protocols that address the needs of sponsors. Our experience spans the drug development spectrum from concept through commercialization. In addition, we will ensure that your study will be scientifically rigorous and compliant with the requirements of the applicable jurisdictions (US FDA, Health Canada, and EMEA).
Design and Management of Clinical Project Plans
Gregory Biancone Consulting provides full service Clinical Project Planning and Management services for all phases of clinical research. Specific programs can be provided as full service clinical project management or as individual services.
· Design, communication and implementation of clinical project plans
· Facilitation of budget and contract development/p>· Management of project timelines
· Oversight of CRO and vendor activities
· Provide leadership to project teams
Gregory Biancone Consulting provides full service Clinical Project Planning and Management services for all phases of clinical research. Specific programs can be provided as full service clinical project management or as individual services.
· Design, communication and implementation of clinical project plans
· Facilitation of budget and contract development/p>· Management of project timelines
· Oversight of CRO and vendor activities
· Provide leadership to project teams
Site Management and Study Monitoring
Gregory Biancone Consulting specializes in full service site management and study monitoring services for all phases of clinical research. Programs are developed that will ensure high quality study performance executed in a cost effective approach without compromising the quality of the data.
Specific services provided:
· Pre-Study and Site Initiation Visits
· Routine Monitoring Visits
· Close-Out Visits
· Clinical Supply Management
· Essential Document Management
· Site Audit Reporting
· Data Management
· Query Resolution
· CRF Review
· Project Management
For each phase of the project, Gregory Biancone Consulting will provide to the client a complete, detailed report pertaining to findings and follow up.
Whether you need full study management and monitoring or individual services, our flexible approach can deliver exactly what you require to get results.
Gregory Biancone Consulting specializes in full service site management and study monitoring services for all phases of clinical research. Programs are developed that will ensure high quality study performance executed in a cost effective approach without compromising the quality of the data.
Specific services provided:
· Pre-Study and Site Initiation Visits
· Routine Monitoring Visits
· Close-Out Visits
· Clinical Supply Management
· Essential Document Management
· Site Audit Reporting
· Data Management
· Query Resolution
· CRF Review
· Project Management
For each phase of the project, Gregory Biancone Consulting will provide to the client a complete, detailed report pertaining to findings and follow up.
Whether you need full study management and monitoring or individual services, our flexible approach can deliver exactly what you require to get results.
Clinical Summary Reporting and Medical Writing Services
A scientifically accurate clinical study report is a key milestone in any clinical research project. Gregory Biancone Consulting will partner with your organization to develop a fully integrated clinical summary suitable for inclusion into product submissions or for publication.
Specific medical writing services offered include:
· Study Protocols and Case Report Forms
· Informed Consent documents and Submisions
· Investigator Brochures
· Investigational New Drug Applications (IND's)
· New Drug Application (NDA) and Supplemental NDA Summary Documents
· Scientific Abstracts
· Manuscripts
A scientifically accurate clinical study report is a key milestone in any clinical research project. Gregory Biancone Consulting will partner with your organization to develop a fully integrated clinical summary suitable for inclusion into product submissions or for publication.
Specific medical writing services offered include:
· Study Protocols and Case Report Forms
· Informed Consent documents and Submisions
· Investigator Brochures
· Investigational New Drug Applications (IND's)
· New Drug Application (NDA) and Supplemental NDA Summary Documents
· Scientific Abstracts
· Manuscripts