Functional Expertise

BioBridges’ professionals are engaged as individuals, project teams, and functional teams for project ramp-up and support, functional gaps, vendor oversight, and rescue work. Below are some of the areas in which we can impact your programs. Please contact us for more information and additional services.

Biostatistics

  • Biostatistical strategy and execution, such as agency meetings, program development, DSMB/DMC, and endpoint activities
  • Oversight of CRO analysis and programming activities
  • Statistical Analysis Plan development
  • Study data analysis, data interpretation and reporting
  • SAS programming, including production of tables, listings, figures utilizing CDISC format
  • Input/writing of biostatistical sections of protocols and clinical study reports
  • SOP/Work Instructions development for biostatistics, and SAS Programming

Clinical Development

  • Provide leadership and management oversight for all clinical research and development operations
  • Oversee the design and implementation of effective clinical development plans
  • Identify, evaluate, and develop collaborations and alliances necessary to support strategic and operating plans
  • Support corporate development in the review of new product candidates available for in-license or acquisition
  • Interact with C-suite, key opinion leaders, and academic organizations to assure incorporation of latest clinical thinking into clinical development plans
  • Cross-functional management of product candidate(s)
  • Technology transfer integration
  • Strategic planning and resourcing
  • Due diligence research and planning
  • Program and project management, resource planning, and budgeting

Clinical Operations

  • Clinical project management
  • Study and site management
  • Representation at management review meetings
  • CRO and vendor selection and management
  • Supply chain oversight
  • Site monitoring
  • SOP/Work instructions development for clinical operations activities
  • Trial master file management

Data Management

  • CRO/EDC vendor selection
  • CRO /EDC vendor oversight of data management activities
  • Develop/review data management plan
  • Develop/review case report forms
  • User acceptance testing
  • SOP/Work instruction development
  • Data review, including clean, query and validate data in preparation for analysis
  • Data coding, including adverse events, con meds, etc.

Medical Affairs

  • Early stage (phase 1/translational) indication, epidemiology, and patient assessment and recommendations
  • Initiation and build out of medical affairs functions, such as medical information, medical communications, etc.
  • Key opinion leader/investigator mapping, development, and management
  • Portfolio and lifecycle management
  • Pre-launch, launch, and post-launch medical strategy, operations, and management
  • Promotional and medical materials review committee support
  • Strategic data dissemination and publications strategy and execution
  • Study design and oversight: natural history, phase 4, registry studies

Medical Oversight

  • Clinical program leadership, such as therapeutic area leads, key opinion leader/investigator engagement, and indication evaluation
  • Clinical study development, oversight, and reporting
  • Medical monitoring
  • Translational evaluation and management

Medical/Scientific Writing

  • Document quality assurance, such as QC and editing
  • Oversight of CRO writing activities, including CSRs, protocols
  • Publications writing and management for both nonclinical and clinical manuscripts
  • Regulatory document writing and management, including CMC, nonclinical, and clinical
  • SOP/Work instructions development for document development processes
  • Submission document management

Quality Assurance

  • SOP/Work instructions for quality activities
  • Site and vendor qualification and auditing
  • Internal sponsor audits of SOPs
  • CAPA generation, oversight of corrective actions, and closure
  • Batch record review and release
  • Inspection readiness
  • Manufacturing oversight

Regulatory Affairs

  • Strategic consulting
  • Coordinate registration and licensing activities
  • Manage and ensure compliance with reporting requirements
  • Technology transfer and asset integration
  • Labeling development and review
  • Regulatory operations support
  • Regulatory project management
  • SOP/Work instructions for regulatory activities

Safety & Pharmacovigilance

  • Case processing
  • Oversight of CRO of pharmacovigilance activities
  • REMS and risk/benefit analysis
  • SOP/Work instructions development for pharmacovigilance activities
  • Clinical trial and postmarket case processing
  • CRO oversight of safety related activities
  • Global aggregate safety report preparation
  • Development of Risk Management Plans/REMS and Risk/Benefit analysis
  • SOP/Work instructions development for clinical trial safety/pharmacovigilance activities
  • Strategic consulting