Partnering & Outsourcing Editorial
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CRO Report Notes Issues With Clinical Applications
3/15/2021
Veeva has released its annual CRO report which examines progress toward modernizing clinical operations. The report gathers the experiences and opinions of CROs around the world and details drivers, barriers, and benefits of a unified operating model from the CRO perspective.
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How To Be A Better Partner To Sites During A Pandemic
3/8/2021
I interviewed a site professional to get her perspective on clinical trials in 2020, where we currently stand, and what she believes sponsor companies need to do if they truly want to become a sponsor of choice for clinical research sites. COVID brought a lot of challenges to the world of clinical research, but the industry is in a good position to incorporate change for all stakeholders.
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The Asia-Pacific Region: A Hot Spot For Clinical Trials
3/2/2021
The Asia-Pacific region has become the hot spot for conducting clinical trials. Why? There is an ease of regulatory compliance, a low cost of conducting studies, a growing patient population, and the presence of a few top clinical institutions acting as sites.
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Appili’s CRO Selection Reflects Realities of Clinical Studies in a Pandemic
2/25/2021
When Appili Therapeutics was ready to enter a Phase 3 trial for a COVID-19 treatment, the CRO selection process was tightly linked to the fact that the company would be conducting the study on infected patients during a global pandemic.
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An Experienced CRO And Sites Lead To Patient Recruitment Success
2/18/2021
Bone Therapeutics has a unique approach to the development of cell therapy products for orthopedics and bone diseases which uses differentiated bone-forming cells. The company was in the process of launching a Phase 3 trial last year when the COVID-19 pandemic was hitting numerous countries. With the help of a CRO and sites experienced in bone diseases, the company was able to complete recruitment successfully and on time.
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Insource, Outsource, Or Both? Choosing The Right Model For Your Clinical Workforce
2/16/2021
While traditional full-service outsourcing is still prevalent (and practically required for small or virtual biotech companies), and some organizations continue to maintain permanent in-house clinical teams, many others — especially midsize and larger organizations — are increasingly taking advantage of other models.
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Why Did Veeva Become A Public Benefit Corporation?
2/11/2021
On February 1, 2021 Veeva Systems officially became a Public Benefit Corporation (PBC). With this move, it becomes the first technology company supporting life sciences to transition to a PBC and is also the first publicly traded corporation in any industry to make that move. How will the designation benefit he company?
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How Ionis Pharmaceuticals Is Advancing Multiple Late-Stage Trials During COVID
2/8/2021
Ionis Pharmaceuticals has experienced substantial growth since its founding in 1990. The company used to boast that it had one drug for every 10 employees, from the cleaning staff up to the CEO. With the acquisition of Akcea Therapeutics in the fall of 2020, Ionis now has a pipeline of 47 products based on its antisense technology platform, which allows for the rapid discovery of new drugs.
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You’re A Small Biotech — How Should You Implement A Pharmacovigilance System?
1/28/2021
When it comes to implementing strong PV practices at your company, there are a variety of components and capabilities to put in place. I’ve been on both the Big Pharma and biotech sides of this debate. With this knowledge in hand, I can help answer some of the commonly asked questions raised about PV best practices.
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Tips For Establishing & Maintaining An Effective CRO Partnership
12/22/2020
Strategic CRO partnerships can accelerate timelines, improve efficiencies, enable access to global footprint, and leverage the continuation of corporate knowledge and domain expertise. However, these relationships require constant nurturing and engagement as well as mutual widespread investment between both parties.