Please write a high level concise brief masters level paper answering the two following questions: ...

Question

Please write a high level concise brief masters level paper answering the two following questions:

1. What is clinical operations, who are the key players, and what is the role of the Sponsor?

2. What do you think some challenges might be in conducting the various possible phases and types of clinical research study designs; what about a Randomized Control Trial specifically?

**Please utilize the following YouTube videos as well as the Attached PDF, which is requirement of the paper**

(Clinical Operations, Clinical Trials and Study Designs)https://www.youtube.com/watch?v=dzhaxgvMj_4&t=51s

(Sponsor, CROs, and Study Sites)https://www.youtube.com/watch?v=FKF_46bTKQc

(Clinical Trials & Drug Development)https://www.youtube.com/watch?v=BOA_9imGCHs&t=2s

(Clinical research study designs)https://www.youtube.com/watch?v=2Fx7Ttsc6qE

Additional resources/readings:

https://www.pharmexec.com/view/pandemic-alters-policies-and-practices-for-drug-development

https://www.thelancet.com/journals/langlo/article/PIIS2214-109X XXXXXXXXXX/fulltext

https://www.youtube.com/watch?v=pm1igf85uoA

https://www.youtube.com/watch?v=RGR4ZQPtcCM&t=2s

https://www.youtube.com/watch?v=CTdH2OWJ-o8

clinical-operations-clinical-trials-and-study-designs-1-wzyxbpx2.pptx

Bidusha · Accepted Answer

Question & Answers		4
QUESTION AND ANSWERS
Table of Contents
Answer 1	3
Answer 2	5
References	7
Answer 1
The Clinical Operations bunch (once in a while known as "Clin Ops") is liable for the organization of clinical examinations. Be that as it may, it is generally misconstrued by different gatherings, remembering those working for biotech and drug organizations. It's additionally hard to characterize its motivation briefly in light of the fact that there are a few. Clin Ops, then again, should be perceived by everybody. All things considered, "significant" bunches get more noteworthy assets and help from neighboring gatherings from the executives.
Clinical Operations is the paste that keeps each of the partners intact. Clinical preliminary groups are frequently comprised of individuals from numerous divisions. The group is comprised of individuals from a few divisions. Clinical Operations might be considered an office inside a wheel talked (YouTube, 2022). This spoke is encircled by different divisions:
· Clinical Science
· Promoting
· Information Management
· Legitimate
· Measurements
· Administrative
· Wellbeing (Pharmacovigilance)
Clin Ops stays in contact with each gathering consistently. This keeps individuals informed about the preliminaries that are mean a lot to them. If not for Clin Ops' assistance, certain gatherings may very well won't ever associate. What's more, in a confounded endeavor like a clinical report, it's important that everybody be in total agreement with regards to methodology, dangers, and current information. Clinical Operations should work together with inside as well as outer gatherings:
· Contract Research Organizations (CROs)
· ePRO Vendor
· Focal Lab Vendor
· IXRS Vendor
· Focal Imaging Vendor
· Other Study Vendors
· Specialty Lab Vendors
Clin Ops might come up short on allure and sparkle of Clinical Science and Marketing. Be that as it may, as a result of its variety, it contains a smidgen of everything. Science, clinical, project the board, tasks, promoting, lawful,

Please write a high level concise brief masters level paper answering the two following questions: 1. What is clinical operations, who are the key players, and what is the role of the Sponsor? 2. What...

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