Real-world evidence and its role in healthcare and life sciences

by Dr. Richard Swafford, Senior Principal Industry Strategist Data is integral to what the life sciences industry does. To establish and run clinical trials, companies depend on data about the disease state, the molecule they are working with, similar products on the market and, most crucially, the patient. Aside from advancing clinical trial recruitment, access […]

Reimagining patient centricity and healthcare practitioner engagement for 2020

by Satish Pandelenghat and Manjunath Shanabag The relationship between the life sciences industry and healthcare practitioners has changed dramatically in recent years. It wasn’t that long ago that sales reps visited each practice to provide information about new products. That changed in the late 1990s and early 2000s as information became more digital. Now what […]

4 considerations when choosing a solution for managing global regulatory submissions

by Dawn Waite and Sadia Ahmed There are so many balls in the air when managing global regulatory submissions that it’s all too easy to lose sight of the bigger picture. That picture really should be focusing on the portfolio, building your regulatory intelligence and strengthening your position in the market. But the day-to-day strain […]

Uncovering efficiencies in clinical drug trials related to the trial master file

by William Hamilton and Gireesh Gaonkar How best to manage the trial master file is a subject of much debate for pharmaceutical companies. Is an electronic trial master file (eTMF) necessarily the right approach? Who are the stakeholders involved in managing the trial master file? And how do you ensure clear lines of accountability with […]

Price alert: What state transparency laws will mean for pharma companies

by Manjunath Shanabag and Satish Nair Pharmaceutical and biotechnology companies are under pressure to manage their complex pricing environment in the wake of new state laws on price transparency. These laws were passed to deal with ongoing concerns about the growing cost of healthcare in the United States. In response, state governments have been taking steps […]

From manual to electronic: Taking the pain out of the trial master file processes

by William Hamilton Life sciences companies have long struggled with inefficiencies and inconsistencies with their trial master file (TMF) processes. Certainly, manual TMF processes leave many gaps and make it difficult for companies to maintain their clinical documentation sets, but this problem is not exclusive to manual processes. Even companies that have partially or completely […]

What life sciences companies stand to gain from integrating regulatory content management and publishing

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By Sadia Ahmed Life sciences companies are increasingly looking for better integration and interoperability across their various content management systems and improved oversight of regulatory content to address both compliance and efficiency demands. This is particularly important for regulatory publishing amid a push to improve both data quality and processes. While a content management system […]

Doing more with less puts automation at the center of the submission process

By Sadia Ahmed and Marcy Miller The days of throwing money into research without clear objectives and goals for getting to market are gone for most life sciences companies. Today, the pressure is on to cut costs and to find ways to bring drugs to market — and to the patients who need them — […]

Life sciences 3.0: How an integrated environment can deliver healthier outcomes

By Sharad Khusal A new, connected dynamic is making its way into the life sciences and healthcare industries, shifting companies from a traditionally siloed approach to an integrated 3.0 environment. Here the emphasis is on a healthy outcomes ecosystem — one that spans nontraditional players such as IT, retailers and nonprofit organizations. At the heart […]

From R&D to health outcomes: Why a connected life sciences platform matters

by Sharad Khusal The life sciences business model is changing. In the past, companies typically worked with fewer partners, most often collaborating only with the physician, or indirectly, with patients. That later expanded to liaising with academia and the contract research organizations (CROs) directly affiliated with them. Today, those walls have come down and pharmaceutical […]