Pietrek Associates consultants provide their services globally.
Clinical Development
Tailored strategies to support accelerated time to market.
Benefit / Risk Evaluations
Do you need to prepare a benefit-risk assessment? We can assist you with a pragmatic, tailored approach using the BRAT framework. Pietrek Associates provide safety and risk management services that lead to understanding issues and minimizing the risks.
Pharmacovigilance
Where to find solutions for both managing routine safety and expert safety? Our consultants will take on PBRER/RMP writing, signal detection and management, develop and implement risk minimization measures, and monitor their effectiveness.
Epidemiology Reviews & NIS Design
Building on a diverse background and careers in academia, regulatory agencies and industry Pietrek Associates consultants have contributed their pharmacoepidemiology expertise to a number of new marketing authorizations, variations as well as routine and ad-hoc management of safety concerns.
Quality Management
QM services include consultancy for enhancement of quality systems across R&D, Medical Affairs and Marketing, in addition to more than 450 GVP and GCP audits, mock inspections and training for inspection readiness.
Vendor Selection and Monitoring
Our insights into clients and service providers enable us to propose competitive resource models with different sourcing options. We generate detailed RFPs, budget spreadsheets, select vendors, support the operational aspects of the contractual agreements and monitor the vendor performance/compliance.
Training and Education
"Best presentation of the whole course with examples from practice"
Participant, European Organisation for Research and Treatment of Cancer (EORTC) course 2011
Quotes from senior expert feedback DIA presentations
"I did not expect pharmacovigilance to be so exciting"
Participant, PV Module, EUCRAF 2
Due Diligence and Competitor Review
As a consequence of Pietrek Associates reputation in the safety area as well as in phase I- IV interventional and non-interventional studies, we have been asked to carry out several due diligence and competitor review projects.