Emanate Blog

Is Clinical Data Management the Next Taxi-vs-Uber Situation? Post Date: 11/21/2019 Embracing digitization within our various companies is good. But as an industry we need to shake some of our resistance to change and newness, and start thinking in terms of how to modernize the industry as a whole through innovations like connected systems. How can we make digitization work for us holistically? The Big Nine are coming for our data...and our clinical trials. They are experts at data, and experts at taking their service or product directly to the people. If we, the clinical operations folks and the data managers, want to have a say in how our industry is reshaped we need to come together and find ways to make meaningful change now, before we are sidelined a la taxi cabs in the Uber disruption. Find out more →		The Detectives of the Pharma World: A Conversation with Bethany Van Veen Post Date: 11/21/2019 20 years ago, as the "safety" people, pharmacovigilance wasn't even part of the conversation in early development until there was a serious adverse event. Now, they are part of the design of clinical trials from the start. Bethany thinks that pharmacovigilance is also the most exciting field within the pharma industry, in part because it incorporates elements of data management, operations, quality assurance, clinical science, regulatory, legal, and technology. It also demands someone with a curiosity about the world, a desire to learn, a logical turn of mind, attention to detail. and good critical thinking skills. Find out more →

Talent Spotlight—Shweta, Clinical Data Manager Rockstar Post Date: 11/21/2019 One of our Rockstar Data Managers, Shweta gracefully juggles multiple technical responsibilities while maintaining the engagement of her team. She gets support and buy-in from her people even in challenging situations and focuses on clear communication, genuine expression of appreciation, and trust-building. Find out more →		Talent Spotlight – Amy P Post Date: 09/13/2019 "Let's figure out how we fix this problem in the shortest amount of time, but still with the highest quality. There can be an element of hunting for the needle in the haystack, and I really enjoy that challenge even now." ~ Amy P. As an Associate Director of clinical data management, Amy combines rigorous, detail-oriented project management skills with a lively curiosity and a genuine empathy and compassion for both the people she works WITH and the people she works FOR. Find out more →

Can AI Speed Clinical Trials? Post Date: 09/13/2019 It's hard to open your news feed or read an industry publication these days without seeing reference to artificial intelligence (AI) or machine learning. AI offers opportunities for the life sciences industries as well, though progress has been slow. In particular, AI may be the answer to the biotech and pharma question, “How do we get life-saving therapies and devices to market faster?” Find out more →		Giving it All Away: A Conversation with Kunal Sampat Post Date: 09/13/2019 Kunal Sampat, like so many in the clinical research field, came to his career in a roundabout way. Even before he was an undergraduate student, Kunal had a desire to help people. He was certain that he would do that through practicing medicine. “A lot of people think they want to be doctors, but don’t see these alternative paths to related and potentially highly satisfying careers, like clinical research.” Find out more →

Big Data, Digital Health, and the Future of Medicine: A Conversation with Charles Wolfus Post Date: 07/17/2019 Emanate speaks with Charles Wolfus, biotech thought leader. We discuss the future of health, or digital health, and the unique perspective IT leaders can bring to biotech, medical device, and pharmaceutical companies. Find out more →		CRO & Sponsor: Effective Relationships from the Start Post Date: 06/18/2019 Just a little extra effort to build strong CRO/Sponsor relationships from the start can keep your clinical trial on track, keep your data clean, and can reduce your expenses. Find out more →

Major Trends in Life Sciences in 2019 Post Date: 01/11/2019 While we’re not psychic and we don’t have a magic crystal ball to peer into, we do notice that some trends appear to be emerging in life sciences, and we want to share these trends with you. Whether you’ve been working in any of the life sciences careers for many years, or you’re still in school and on track to graduate with your degree this year, you may benefit from knowing what these trends are. Find out more →		How To Be Genuine When Networking In The Life Sciences Fields Post Date: 11/14/2018 Everyone knows that in the fields of technology, science, and research, the job market is quite competitive in the Bay Area. Whether you’re in San Francisco, San Jose, Santa Cruz, or elsewhere in this northern California region, you need to have outstanding networking skills to get the job you want. Part of the skills set you must cultivate involves knowing how to be genuine (but never desperate!) when networking. Find out more →

My First Collaborations in Clinical Research Event Post Date: 05/28/2018 What struck me as interesting was the variety of people in attendance. There were professionals who had 30 years in the industry chatting with newcomers just finding their place in the world of clinical science, and even a number of recent grads. With so much innovation and advancement in the industry, it makes sense that everyone from top to bottom would want to gain a better understanding of what the field of data management looks like today. Find out more →		The Interview: What do you need to know about data management Post Date: 03/31/2018 This is a transcript of our: Clinical Trials: What do you need to know about Data Management event - an in depth Q&A on Clinical Data Management. Find out more →

ICH E6 – Summary of Changes Post Date: 02/16/2017 ICH E6 Good Clinical Practice is an international scientific and ethical quality standard for conducting, designing, recording and reporting trials involving human participation. It provides the public with assurance that all rights and safety of trial subjects are protected and consistent with the principles that originate in the Declaration of Helsinki and clinical data. Find out more →		Series: Selecting an EDC Part II Post Date: 10/11/2016 Selecting an Electronic Data Capture (EDC) vendor and system is a daunting task. This is true for sponsors choosing systems in a study-by-study model where there is a desire to optimize the solution for each study. There are a number of important considerations to take into account when selecting an EDC solution for your clinical trial. Find out more →

Series: Selecting an EDC Part I Post Date: 09/09/2016 Selecting an Electronic Data Capture (EDC) vendor and system is a daunting task. This is true for sponsors choosing systems in a study-by-study model where there is a desire to optimize the solution for each study. There are a number of important considerations to take into account when selecting an EDC solution for your clinical trial. The next few weeks we will discuss these topics. Find out more →