Clinical trial supply management

This presentation comprises information about clinical trial supply management.

1. Clinical Trial Supply Management Prepared By: Dipesh Kashinath Pabrekar 1

2. Clinical Trial Supply & Logistics Market - Insight Clinical trial supply and logistics is a management that is responsible for providing clinical supplies needed for clinical studies of drugs or medical devices in accordance with protocol and applicable regulatory requirements. This process involves oversight of the planning, packaging, forecasting, labeling, sourcing, distribution, and clinical supplies for government and commercial sponsors whose studies are in phase 1-4 clinical trials . The global clinical trial supply and logistics market size was valued at  US$ 14.95 Bn  in 2017 and is expected to witness a CAGR of  7.1%  over the forecast period (2018 – 2026). 2 Ref: https ://www.coherentmarketinsights.com/market-insight/clinical-trial-supply-and-logistics-market-1798

3. Market Regional Outlook On the basis of region, the global clinical trial supply and logistics market is segmented into North America, Europe, Asia Pacific, Latin America, Middle East, and Africa . The number of new vendors trying to enter the healthcare industry are expected to increase over the forecast period, as there are many niche market players trying to leverage the market share through new inventories in medical devices and drugs . emerging economies such as Asia Pacific and Latin America has huge potential for market growth, and is projected to be the fastest growing region over the forecast period. 3 Ref: https ://www.coherentmarketinsights.com/market-insight/clinical-trial-supply-and-logistics-market-1798

4. Key Players in Clinical Trial Supplies Some of the key players operating in the global clinical trial supply and logistics market include 4

5. What is Investigational Medicinal Product (IMP) ICH E6- 1.33 Investigational Product: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. 5

6. IMP Supply Management It is the journey where GMP meets GDP and GCP and this journey includes flow of products, information, finances and documents and how a company manages this journey know as supply chain management. 6

7. Clinical Trial Supply Chain Interfaces 7

8. Key Objectives of CTS Get The Right Drug To The Right Patient In The Right Time And Condition Enrollment rates and dynamics Changes in site status can affect supply strategies Managing Customers Maintain good relationship with all relevant stakeholders Retest Process Expiration of IP, resupply packaging lead time to the site Storage Storage capacity, storage equipment of site and size of the shipper Shipping TOT Primary and secondary transport. Site to patient delivery 8

9. Project Manager QA Regulatory DM Bio stats IRT RTSM Vendor CMO CRO CTm CRA Includes field monitors and site coordinators Includes Toxicologist (Phase 1 trials) & stability scientist Includes qualified person, QA, auditors Includes data team and statistical programmer Includes CTSM admin, forecasting analyst Includes 3PL depots, courier services CTS Management Stakeholders 9

10. CTS Project Kick Off Guide 10

11. Project analysis slide 2 Challenges in CTS Management CTS Challenges Lack of data for Accurate forecast Cross vendor alignment Logistical Challenges Multiple Languages Country Specific Regulations Patient Enrollment Shorter time 11

12. Form cross functional strategic partnership to mitigate risk, time and cost. Marketers must link the price to the real and perceived value of the product, but they also must take into account. 03 04 Measures to tackle CTS challenges Pre defined work processes for external stakeholders Active engagement in timeline management across cross function deliverables Less experienced sponsors may opt for partnership with service providers to reduce CTS challenges IRT could be critical success factor in proper supply management. Review, monitor and validate processes and system 12

13. Current Trends in Clinical Trial Supply Pharmaceutical companies are progressively partnering with service providers to manage their supply chain Moving from ad hock interactions to partnership based relationship Supply chain organizational structure is becoming more and more complex More trials, more regulations, more regions, more resources Increase in cold chain logistics and distribution Due to shift from small to large molecule of drugs Accurate supply forecasting becoming even more significant. 13

14. Thank You 14