Lecture 3 Flashcards
What is BIMO?
bioresearch monitoring
What are the different conclusions of inspections?
- No Action Indicated (NAI)
- Voluntary Action Indicated (VAI)
- Official Action Indicated (OAI)
What are most common CI deficiencies?
- failure to follow investigational plan
- protocol deviations
- inadequate record-keeping
- inadequate accountability for the investigational product
- inadequate subject protection, including informed consent issues
What are the most common IRB (institutional review board) deficiencies?
- Inadequate initial and/or continuing review
- inadequate SOPs
- Inadequate membership rosters
- inadequate meeting minutes
What are the most common S/M deficiencies?
- inadequate monitoring
- failure to bring investigators into compliance
- inadequate accountability for the investigational product
What is BEQ?
bioquivalence
What are some BEQ deficiencies?
- dosage issues
- analytical concerns
What are the most common GLP deficiencies?
- incomplete/inaccurate study reports
- incomplete/inadequate/no study records
- inadequate/no SOPs
- personnel failure to fulfil responsibilities
- archive docs improperly filed and/or not retrievable
What are the program objectives of ‘division of foreign field investigations’?
- coordinate foreign travel for ORA (office of regulatory affairs)
- to accomplish international inspections
- to ensure the most efficient use of budget and human resources
What are the most common FDA warning letter citations?
- failure by clinical investigators to adhere to the approved protocol
- failure to protect rights and welfare os study subjects
- failure to maintain accurate and complete case histories
- failure to maintain accurate IP accountability
What has contributed to the increasing costs of drug development over the past couple of decades?
- more stringent regulatory requirements
–> higher clinical trial costs - growing complexity of new drug candidates/therapies
What challenges do emerging small biotech companies face?
- face high business entry hurdle
- limited resources - both human and financial
- strategy to get the development process starts
- finance the company during the development process
What are the advantages of outsourcing in pharma industry?
- flexible team structure
- flexibility in service models
- flexibility in budgeting the program development
- reduce the entry hurdle to the industry
- risk sharing – data quality
What are CROs?
service providers that offer clinical research services for pharmaceutical and biotechnology companies.
They assist in managing and executing clinical trials efficiently.
What are the 2 types of CROs?
- functional CROs
–> specialize functions e.g. clinical data
management or regulatory affairs - full-service CROs
–> handle full spectrum of drug
development, study to monitoring
What are the main CRO services?
- clinical trial management
- regulatory services
- data management and analysis
What are some services provided by full-service providers?
clinical trial design, site selection, patient recruitment, data management, regulatory submissions, and post-market surveillance
What are some services provided by functional service providers?
data management, biostatistics, clinical monitoring, regulatory affairs
How do full service providers differ from functional service providers in terms of scope of business?
full: comprehensive
functional: specialized
How do full service providers differ from functional service providers in terms of project management?
full: single point of contact
functional: multiple points of contact, may require internal coordination
How do full service providers differ from functional service providers in terms of flexibility?
full: less flexbile, more standardized process
functional: high flexibilty, tailored to specific needs
In what areas do full service providers differ from functional service providers?
- scope of business
- project management
- flexibility
Functional service providers are suitable for companies with strong internal project management.
True or false?
True
Functional service providers are suitable for companies which would like to augment internal expertise and resources.
True or false?
True
What factors to consider when choosing between full-service providers and functional service providers?
- Consider company size and internal
capabilities - Assess project complexity and scope
- Evaluate budget and resource availability
- Determine the level of control and
flexibility needed
What are the steps to choosing a CRO?
- define your needs
- research potential CROs
- prepare a Request for Information (RFI)
- send RFI to shortlisted CROs
- obtain proposals and pricing
- conduct interviews and site visits
- Select the CRO
CROs encounter several regulatory challenges that complicate their operations and impact trial success.
What are those challenges?
- compliance with regulations
- data privacy issues
- variability of standards
–> different countries have different regulations and guidlines for clinical trials
What are the major cost components of clinical trials?
- patient recruitment and retention
- site management
- clinical supplies
- data management and analysis
- regulatory compliance
- administrative costs
