OUTSOURCING Resilience amid Covid-19
QPS discusses the five keys it has developed for CROs to maintain full operations during the Covid-19 pandemic and build resilience. To help other CROs develop a strong plan for
local governments have issued stay-at-home mandates, major events have been cancelled, businesses have closed – some temporarily, some permanently – and health officials are discussing the best way to safely reopen. Knowledge of Covid-19 is changing rapidly as scientists continue to explore the transmission of the disease, the variance between cases, testing modalities, and potential treatments and vaccines. Until a vaccine or effective treatment is widely
C
available or herd immunity occurs, life cannot return to normal. Since the development of a new vaccine is a time-consuming process, businesses – including contract research organisations (CROs) – that wish to succeed during this difficult time must adapt to the circumstances and develop resilience. In response to the pandemic, QPS has
overhauled daily operations at its 11 locations around the world. From clinical trial recruitment and study protocols to collaboration with sponsors and hiring shipping vendors, its team has made significant changes. QPS hopes that these adjustments will ensure the health and safety of its employees, and help its business remain fully operational during this uncertain time.
ovid-19 has upended daily life in almost every country around the world since WHO declared it a pandemic. National, state and
success, it has developed five core attributes that CROs need to take into consideration to maintain full service operations and build resilience during this time: safety, collaboration, assessment, regulations and flexibility (SCARF). Many CROs are struggling to understand and address the challenges presented by the Covid-19 outbreak, but only those CROs who rapidly respond to the ever-changing situation will be likely to succeed. Now is the time to build resilience.
Safety To ensure the safety of the study subjects and staff, CROs must develop and maintain rigorous hygiene standards based on the guidelines published by health authorities. As the standards may change over time, it’s important to regularly monitor the criteria, adapt procedures and implement new strategies as needed. At QPS, all participants, study subjects and
potential subjects are asked questions regarding their recent contacts, travel history and potential Covid-19 symptoms during the initial phone screening. Individuals identified as ‘at risk’ are not invited to visit the clinics. Upon arrival at a clinic for an in-person screening, participants complete a questionnaire to determine if they are exhibiting any characteristics associated with Covid-19. In addition, they are housed in a designated area away from active study participants while they are tested for Covid-19, using a polymerase chain reaction (PCR) test. If their results are negative, they progress to enrolment in a separate part of the building. Throughout all procedures, CRO staff should maintain strict hygiene standards. For example, they should wear personal protective equipment (PPE) while on-site and follow all applicable local guidelines while not at the facility. CROs should encourage hand sanitisation when someone enters the clinic, provide participants with masks and request that they observe all applicable social distancing guidelines. In addition, CROs
14 | 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 |
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
