CONTENTS
Contents 5.
How to streamline a complex process: why experienced medical writers will add value to oncology dossiers Getting approval for new drugs can be complicated. Trilogy Writing & Consulting reveals how medical writers can help
8. 9.
Chapter 1: Outsourcing and clinical operations
Assessing the short to long-term impacts of COVID-19 on oncology trials Nouscom’s on a decentralised approach and faster uptake of technology
12.
Oncology, COVID-19 and clinical trial comparator challenges in 2021 Aposave’s reveals the results generated by the company’s second annual survey of clinical trial professionals
16.
Scenario planning as a risk management tool for small and emerging biotechs , of pioneer cancer research company Biosceptre International, takes a targeted approach to treatment programmes
19.
A guide to how IRT supports oncology trials from early phase to completion Suvoda shares how IRT can help manage the complexities of oncology trials using a flexible, validated system
23. 25.
Chapter 2: Immunotherapy
Lining up a fresh approach to how we measure the efficacy of oncology-based therapies Why it is critical to explore the various end points when developing these therapies, as discussed by from Janssen
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35. 36.
27.
Clinical trials are changing – along with support requirements It is essential to have proof of efficacy, tolerance and safety before a new drug or procedure can come safely to market
29.
Integrating biomarkers in oncology trials and routine practice may boost progress from PureTech Health reveals why validated biomarkers may result in value for medicines
32.
What to consider when running a clinical trial
Double Bond Pharmaceutical’s looks at innovative product development in the field of rare diseases in oncology and lung infections
Chapter 3: Patient and data innovation in oncology
Why synthetic control arms can be good news during clinical trials Modra Pharmaceuticals’s Putten on the benefits of using synthetic patients to boost trial outcomes
39.
The importance of a clinical data manager in management strategies , from Inspirna, explains why the management of the data collection phase is key to its success
The data skills behind the clinical trials An appreciation of data and the related technology is good for management, says Ascendis Pharma’s
45. Suppliers’ Directory
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