Epidemiology Services

Services are applicable to clinical development and the post-authorization period.

• Systematic literature review of targeted indication
• Definition of unmet medical need
• Design of natural history of disease studies
• Identification of data sources for observational studies
• Review of study options and appraisal of feasibility
• Quantification of disease-specific adverse events
• Pharmacoepidemiology for safety signal investigation
• Support of consultations with regulatory authorities
• Project management of pharmacoepidemiology studies
• Training on pharmacoepidemiology

Examples

1. Systematic Literature Review of Acute Coronary Syndrome and Coronary Artery Disease regarding incidence, prevalence and outcome worldwide, trends in country-specific risk factors, review of North American and European treatment guidelines and their implementation, evaluation of effectiveness of selected treatment for secondary prevention, involving >20,000 scientific publications from 1990 to 2009.
2. For gene therapy design of observational safety study and controlled drug distribution program in several European countries, including the collection of corresponding regulatory requirements with respect to legal representation, ATMPs, data privacy etc.

Pharmacovigilance / Risk Management Services

Do you need support to get ready for the new European PV legislation?
Pietrek Associates can help you in developing short- and long-term solutions for the revised operational models.

Additional consultancy and operational support related to

• Product-specific safety planning
• Management of safety concerns
• Design and conduct of post-authorization safety studies
• Pharmacovigilance and risk management systems
• Support of interaction with regulatory agencies
• Pharmacovigilance quality management
• Project management and vendor oversight
• Failure modes and effects analysis (FMEA)
• Risk Minimization strategies and effectiveness
• Outsourcing strategies, qualification of providers & project management
• Generation of drug safety agreements for licensing partners

Examples

1. Review of EU risk management strategy during Marketing Authorization Application (MAA)
2. Support of rectification of pharmacovigilance inspection findings
3. Generation of PV Quality Management Systems (QMS) and Standard Operating Procedures (SOPs)
4. Ad-hoc and regular Safety Advisory Boards
5. Review of Risk Management Plans for innovative therapies
6. Country-specific, regulatory PASS requirements
7. Protocol design of post-authorization safety study (PASS)
8. Support for 120 day response to EMA
9. Day-to-day safety monitoring of authorized medicinal products

Clinical Development Services

Strategic Advice

• Design of clinical development programs including budget estimates
• Generation of Safety Development Plans
• Outsourcing strategies & qualification of service providers, oversight / project management
• Design of clinical trials & observational studies, patient recruitment strategies

Operational Support

• Generation & review of core documents such as business plans, study protocols, correspondence with regulatory authorities, ethics committees / IRBs & investigators
• Set-up, management & support of Data Safety Monitoring Committees, including training
• Therapeutic expertise throughout the clinical development / medical monitoring

 Examples

1. Cumulative safety reviews prior to new drug application
2. Support of Common Technical Documents (CTDs) for Marketing Authorization Application (MAA) submissions, resulting in successful marketing authorizations
3. Qualification of global CRO
4. Definition of outsourcing needs, identification of vendors and support of CRO selection
5. Definition of clinical criteria for new product target profile
6. Medical monitoring for a medical device
7. Integration for pharmacovigilance / risk management strategy for gene therapy prior to pivotal study
8. Development of robust Phase II design for biological compound resulting in an optimized go / no go decision

“I did not expect pharmacovigilance to be so exciting”
Participant, PV Module, EUCRAF 2011

"Best presentation of the whole course with examples from practice"
Participant, European Organisation for Research and Treatment of Cancer (EORTC) course 2011

Training Services

• Customized training for epidemiology, drug safety, quality & project management, clinical development and therapeutic aspects
• Interactive workshops targeted at operational as well as higher qualified staff members
• MSc Regulatory Affairs for Biopharmaceuticals (EUCRAF) in collaboration with the University of Strasbourg: Module Pharmacovigilance

Examples

1. Train company staff in carrying out internal PV audits
2. Developing specific tutorials associated with Risk Management / Quality Management
3. Interactive workshops using case studies in signal detection / investigation
4. Inspection readiness training
5. On-the-job training of clinical development plan and corresponding safety development plan