CONTENTS Contents
7. 8.
Chapter 1: Clinical operations and outsourcing
How a well-planned clinical trial budget can help prevent burning bridges A poorly negotiated budget can cause friction between sponsors and clinical trial sites.
10.
The lay protocol synopsis: requirements and feasibility Take a look at the new rules for the assessment of clinical trial applications, with Trilogy Consulting & Writing.
14.
What do record CRO M&A deals mean for clinical trial sponsors? Mergers and acquisitions among CROs can diversify clinical trial service offerings, but come with risks attached.
17.
Recognition of the work of a CRO: how is it achieved and why? APICES explores what a CRO can contribute during the clinical research process.
40. 19.
The great wall: why overseas sponsors are yet to fully tap into China’s clinical trial resources China is an attractive study destination, yet its clinical trial industry remains insular, according to analysis by Clinical Trials Arena.
22.
DCT and clinical trial diversity: glass ceiling persists While decentralised clinical trials aim to reduce recruitment barriers, there is still work to be done to ensure diversity among study participants.
24.
Alignment on laboratory support for clinical trials
Q&A with Nan Zhang MD PhD, vice president, global central lab and biomarker
30.
services at contract research organisation (CRO) Frontage.
As Russia’s clinical trial sector falls, Ukraine rebuilds Reynald Castañeda analyses the impact of the war on the clinical trial landscapes of Ukraine and Russia.
33.
Seven ways to reduce the burden of hybrid decentralised trial technology Medrio is on a mission to ease complexity in hybrid, decentralised and site-based clinical trials.
35. 37.
Chapter 2: Technology and data management
Revealed: the pharma companies best equipped with AI
As more and more pharma companies explore the potential of artificial intelligence, untapped opportunities remain in clinical trials.
The evidence for decentralised trials Huma looks at how a groundbreaking trial found rapid recruitment, high patient engagement and increased adherence.
43.
Profit for patients: could NFTs enable people to monetise their health data? Non-fungible tokens could democratise access to health information, but challenges around the nascent technology must first be addressed.
48.
Budgeting for clinical trials: the importance of comparator medicines Clinical Services International (CSI) on the importance of and increasing need for comparator medicines in clinical trials.
4 | Outsourcing in Clinical Trials Handbook
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
