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Outsourcing BA and BE to CRO

The document discusses the concept of outsourcing, particularly in the pharmaceutical industry, and emphasizes its importance for conducting bioavailability and bioequivalence studies. It outlines reasons for outsourcing, typical services provided by contract research organizations (CROs), advantages, and key success elements for these collaborations. Additionally, it highlights critical considerations regarding timing, costs, and potential problems associated with outsourcing.

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By: Sachin M. Chandankar Dept. of Pharmaceutics Outsourcing BA & BE to CRO
• Introduction • Reasons • BA & BE introduction • Typical Services • Advantages • Key elements • Problems • CRO introduction • Summary • Secure steps in outsourcing • Refrences Contents-
Introduction
What is outsourcing • Outsourcing is the business practice of hiring a party outside a company to perform services and create goods that traditionally were performed in-house by the company's own employees and staff. • Outsourcing was first recognized as a business strategy in 1989 and became an integral part of international business economics. • Outsourcing is generally done to reduce the costs and improving the efficient resources within a company. Ex. of outsourcing is bioavailability, bioequivalence, R & D department etc.
Why Outsourcing
Reasons For Outsourcing Clinical Trials
Bioavailability & Bioequivalence ▪ Bioavailability:Measurement of the amount and rate at which the drug from administered dosage form, reaches the systemic circulation and becomes available at the site of action. ▪ Bioavailability describes the concentration of drug in systemic blood in relation to the amount of drug given. ▪ Bioequivalence: It is a relative term which denotes that the drug substance in two or more identical dosage form, reaches the systemic circulation at the same relative rate and to the same relative extent i.e; their plasma concentration-time profiles will be identical without significant statistical differences
Typical services outsourced for BA-BE studies • Bioanalytical studies • Bioanalytical Site Selection and Qualification • Clinical Study Design • Clinical Protocol Development • Clinical Site Selection and Qualification • Clinical Conduct • Clinical Monitoring
Typical services outsourced for BA-BE studies • Data Management • Pharmacokinetic Analyses • Statistical Analyses • Pharmacokinetic Report Writing • Integrated ICH Report Writing • Project Management • FDA/Regulatory Consultation
Advantages • Improved customer service • Increase productivity and efficiency • Better people management • Focus on core competencies • Access to world class solutions • Skilled expertise • Cost savings
Key Elements For Success • Communication at all levels between the CRO and the Pharmaceutical Company. • Sensitivity to both the project specific requirements and timelines. • Flexibility to recognize and adjust to unexpected events throughout the project timeline.
Timing / Cost Considerations • Timing and costs are two major considerations that come into play when a pharmaceutical company decides to outsource. • Timing is even more critical when a generic manufacturer intends to file an ANDA with a Paragraph IV patent certification • The first generic to file (as a paragraph IV) is entitled to 6 months of exclusivity (i.e., no generic competition).
Clinical Site Qualification/Audit- Clinical site evaluation • Assess the volunteer (or patient) population pool • Evaluate CRO procedures for adverse effects investigation • Assess training records for the clinical team • Evaluate CRO’s ability to coordinate plasma/urine shipments to different bioanalytical facilities • Assess ability to coordinate functional handoffs e.g., Timely delivery of protocol to clinic, samples to laboratory, and bioanalytical data. • Assess clinical project management capabilities.
Problems with Outsourcing-
CRO (Contract Research Organisation): • A contract research organisation(CRO) is an organisation that provide support to the pharmaceutical, biotechnology and medical device industries in the form of research services outsourced . • It offers various pharmaceutical research that is essential for conducting clinical trials, the ICH technical requirements for registration of pharmaceuticals for human use.
CRO- • (contract research organization): A CRO is an organisation contracted by another company to manage and lead to the companies trials,duties and functions. • Organisations and businesses that contract with CROs do so to acquire specific expertise without hiring permanent staff. • CRO independent organisation that steps in to the development process once a pharma company has identified a promising new molecule. • Example of CROs include :Quintiles,Covance,Icon,Zydus Cadila and HMR .
Summary • It is critical to the process of working effectively with CROs that client companies (and the CRO) precisely define deliverables and expectations, assign a qualified project team, and develop communications systems that work for both the CRO and client company.
Tips for Secure Outsourcing • Know what you are outsourcing. • Understand risk and dependencies. • Acess outsourcer risk management level. • Ask about training and background checks of personnel level. • Ensure data is protected appropriately.
References- • Overby S, 2007 ABC ; An introduction of outsourcing. • Babu M,2005 Myth; All outsourcing is offshoring. • WWW.CIO.COM • Roothman j,2003; Steps to successful outsourcing. • WWW.COMPUTER.COM
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