IN PARTNERSHIP
correctly. The success of the laboratory change-related process might be monitored with the use of key performance indicators (KPIs) built around change implementation.”
What type of laboratory information system (LIS) and data structure will meet the industry’s future needs? “AI and big data are predicted to be the most disruptive innovations in the next decade or two. A laboratory information system that is compatible with or supports these two critical areas will be most desired. In addition, data curation, data repurposing, as well as AI- assisted modelling would be of great importance. These emerging technologies and applications cost-effectiveness in the lab and the entire clinical trial process, but also inspire ideas for the lab and studies supported by the lab. “During the study set-up phases for
bioanalytical, biomarker, anatomic pathology, and clinical pathology testing, the design and is crucial in many aspects. It will allow easier data sharing, data analysis, or even data repurposing. It is a fundamental requirement for AI and big data applications. Although natural language processing (NLP) has come a long way to help structure free text data, it would be more feasible (both work-flow-wise (at the maximum extent possible) at the data capture and LIS level.”
What is the optimal stance for a laboratory leader to take when faced with misalign- ment challenges? “The leaders of laboratories are the builders of
“AI and big data are predicted to be the most disruptive innovations in the next decade or two. A laboratory information system that is compatible with these two areas will be the most desired”
the long-term success of their institution. Their goal is to make strategic interventions to ensure that the most important links of the laboratory’s value chain – its fundamental design – are seamlessly linked. Laboratory leaders are accountable for conceptualisation, design, diagnosis, and realignment. The most prevalent causes of misalignment are: laboratory administrators are unaware of the dangers posed by misalignment; strategic alignment is hindered by complexity; and progress is confused with activity. Nearly constantly, laboratory leaders should evaluate the strategic alignment of their lab, including the extent to which their business strategy supports the achievement of their company’s long-term purpose and the extent to which their organisational capabilities facilitate the implementation of their business strategy. Using actionable knowledge generated
by a comprehensive diagnostic based on a framework, laboratory executives can identify and prioritise system changes required for improved strategic alignment. When misalignment is found, lab executives should direct a constructive realignment process. This includes visualising and communicating a new strategically aligned direction, educating and engaging others in the principles of the desired way of working, influencing positive changes, and establishing the momentum of the new (or renewed) approach, so that the organisation becomes the new norm.”
What are your predictions for the future? human diseases will occur over the next two decades. We are living in an exciting time as the Different types of cancer and haematological tumours will have a better chance at being successfully treated, and laboratory service delivery that is optimally aligned with clinical trial design and execution will be crucial to support all the exciting advancement in medicine. The time has come.”
References
1. Pallmann, P., Bedding, A.W., Choodari-Oskooei, B. et al. Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Med 16, 29 (2018).
Outsourcing in Clinical Trials Handbook | 27
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
