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FOCUS

• Strategic clinical development advice for biopharmaceutical products
• Set-up, management and interpretation of Phase 1 and 2 studies in USA
• Communication with FDA and international regulatory agencies

HALLMARKS

• Personalized “hands-on” service from experienced project team members
• Work with client to create a partnership
• Take ownership and champion the project
• Flexibility and responsiveness
• Time and budget sensitive (we will negotiate with the study contractors and investigational sites to minimize costs)

EXPERIENCE

• Medical consultants who have worked as clinical reviewers at CBER, FDA
• Clinical trial specialists have considerable industry experience in all aspects of study set-up and management

SERVICES OVERVIEW

Clinical Development

• Perform Gap analysis and due diligence
• Design Clinical Development Plans (CDPs) and clinical strategy
• Provide ongoing clinical and regulatory input for clinical programs
• Represent the Sponsor to FDA
• Review FDA documents prior to submission
• Design clinical studies
• Provide support for clinical component of IND or BLA/NDA submissions

Study Set-up

• Prepare Request for Proposal (RFP)
• Perform Site identification, pre-qualification and Site Qualification Visit (SQV)
• Negotiate Site Budget and prepare site contract/clinical trial agreement
• Collect essential documentation
• Prepare IRB submissions
• Coordinate Investigator Meetings
• Perform Site Initiation Visit (SIV)

Study Documentation

• Write Investigator’s Brochure (IB)
• Write Protocol and Informed Consent Form
• Prepare Case Report Forms (CRFs)
• Create Study Manual
• Assemble Regulatory Binder

FDA IND Submission and Maintenance

• Pre-IND clinical activities and preparation of initial IND
• Prepare  IND amendments
• Perform Pharmacovigilance and Safety reporting

Study Management and Monitoring

• Provide Medical Monitor and coordinate safety review
• Study Monitoring
• Project Management
• Study Product management
• Liaison with large CROs

Advisory Boards

• Identification of medical and/or scientific experts for Advisory Board and management of meetings

Biostatistical Analysis and Data Management

• Prepare Statistical Analysis Plan
• Provide biostatistical input into study design and protocol preparation
• Biostatistical analysis and interpretation of results
• Data management

Medical Writing

• Preparation of Clinical Study Reports directly or  in conjunction with Sponsor or CRO
• Preparation and/or review of pre-IND, IND, BLA and NDA clinical sections

Many clinical trial tasks and resources are pieced together to obtain the final product – a successfully completed study.  All study components, from identifying suitably qualified and engaged investigators with the appropriate patient population to the daily management of study activities and submission of study reports to the FDA, are critical for a successful study.  We will work with you to achieve success.