OUTSOURCING
European sites are defined. Early QP collaboration ensures that the right decisions are made before the time of release. The QP can also be part of the decision-making process if deviations are needed when running a non-validated early phase manufacturing process. Phase I may be the first time a cGMP
process is used during the manufacture of a drug product, which may potentially bring unexpected observations that could result in production being paused. This may lead to different paths forward, the choice of which could affect lead times, especially if supplies are destined for different continents for studies to be undertaken. In these cases, having a clear strategy is important, and should involve both the production site and customer, with input from a QP. – this will be beneficial if supply to Europe is planned. Although a QP is not required by the US FDA, it can be advisable to engage one, particularly if a trial could potentially become global. Establishing a relationship with a QP just in case will ensure that a drug product will conform to both European and US regulations. Phase I packaging and labelling is relatively
simple, involving only a few clinical sites. However, if the molecule progresses, an integrated supplier can provide support and preparation for subsequent phases based on the established relationship between the customer, manufacturer and clinical supplies teams. Not using an integrated supplier and not having clear communication between multiple vendors can mean avoidable delays. For example, a vendor sending thin carton inserts, designed for plastic bottles to prevent rubbing, for a product in glass vials shows a disconnect between the drug producer and packaging supplier. The wrongly engineered packaging can lead to breakage and severely impact delivery schedules to clinical sites. Establishing cross-discipline teams from the
start also allows expertise and experience to be shared in areas such as labelling. Even in studies that are open and involve products without complex label requirements, not engaging with a QP early enough in the process can lead to delays in release if queries are raised regarding information in the label text. However, the simple label requirements in phase I can quickly become more complex
34 | Outsourcing in Clinical Trials Handbook
in phase II and III. Manufacturing and clinical supply team collaboration is the best way to accommodate changing protocol requirements, so that any changes in requirements can be understood and expedited.
According to plan Getting a drug to patients on time and according to plan is critical, and careful preparation and planning is essential. Direct communication between the drug product’s manufacturing and supply teams is optimal. Having a small, close-knit group engaged with customers throughout any project increases the efficiency of the process, reduces the risk of stock-out and a supply chain breakdown, leading to a missed dose. Collaboration between teams supports the use of computerised systems to manage inventory and shipment requests, and can help solve challenges arising from regulatory approval, launch and eventual commercialisation. It is important to take a holistic view of
the product being provided to the clinic. Subject matter experts should be involved throughout the process; when people with different backgrounds look at things from different perspectives they can come up with unique solutions to problems. All parties must communicate and collaborate early, and often. Having an integrated team reduces the
overall risk of issues and delays. With appropriate planning, this can lead to a streamlined programme, avoiding multiple handoffs and reducing the element of risk that they bring. It is the small, overlooked or misunderstood details that can cause the biggest problems in the clinical development process, so leveraging experts will increase insight and gain perspective. Today’s plan must take into consideration tomorrow’s needs, therefore, building strong relationships early creates a team invested in shaping the future. ●
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120
