Electronic document management systems (EDMS) offer excellent version control functionality, but, when it comes to collaboration, they tend to be…clunky, at best. SharePoint 2016, on the other hand, offers the best of both worlds: the security of an EDMS and the collaboration tools of, well, SharePoint. Here’s an example of how a global pharmaceutical company […]
Regulatory Compliance
What Is E2B(R3)?
E2B(R3) doesn’t have a direct translation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) published guidelines that have designated “E” to stand for efficacy. The work carried out by ICH under the efficacy heading relates to the design, conduct, safety, and reporting of clinical trials. It also […]
The DOL’s New Conflict Of Interest Rule, In A Nutshell
In April of this year, the U.S. Department of Labor finalized a new rule that is meant to protect individuals from receiving retirement investment advice that, in reality, may not be in their best interest. It’s a complicated rule that addresses the conflict of interest that financial advisors frequently encounter, such as receiving commission or […]
E2B(R3): Inside Scoop For Product Safety Teams In Life Sciences
The electronic transmission of adverse event information to stakeholders, using the International Conference on Harmonisation “E2B” standard, is an essential component of global drug safety and pharmacovigilance operations. E2B(R3), the latest version of the International Standards Organization (ISO) Individual Case Safety Report (ICSR) standard, includes new requirements with which product manufacturers and the organizations that […]
$17 Million For An Inadequate AML Program
Recent news from the Financial Industry Regulatory Authority (FINRA) reminds us of the importance of having a solid anti-money laundering (AML) compliance program. A well-known financial services company was fined $17 million for not having sufficient processes that could enable them “properly prevent or detect, investigate, and report suspicious activity.” While the organization significantly grew […]
18 Resources For Life Sciences On Digital Transformation
We thought it might be helpful for you if we pulled together all of Perficient’s resources to-date related to digital transformation. Happy discovering! Digital Transformation “Boot Camp” Digital Transformation: Part One: Laying the Groundwork for Success Digital Transformation: Part Two: How the Customer Experience Drives Digital Transformation Digital Transformation: Part Three: Building a Mobile Foundation […]
FDA Draft Guidance: Using EHR Data In Clinical Trials
We’ve talked a lot in this blog about the use of electronic health records (EHRs) in clinical trials. Recently, my colleague wrote about it on our healthcare blog, so, I thought I would share her post with my pharma and CRO friends. While our previous posts focused on the use of EHR for subject recruitment […]
FDA Director: We’re Watching How You Manage Product Complaints
We frequently blog about FDA Warning Letters and other regulatory and compliance issues that revolve around traditional pharmaceuticals and medical devices. However, one product segment that we haven’t yet discussed is digital health. This is because digital health products are fairly new to the market and most are still trying to figure out how FDA […]
FDA Warns An IRB To Document Its Members And Their Votes
I don’t often see FDA Warning Letters issued to Institutional Review Boards (IRBs), so, when I came across this one, I thought it was worth sharing with you. This particular IRB was found to be in violation of 21 CFR Part 56.115(a)(2), related to meeting minutes, and 21 CFR Part 56.115(a)(5), related to a complete […]
Don’t Let Your Investigators Ruin Your Study By Doing This
I enjoy reading FDA Warning Letters. They’re insightful and often entertaining. Sometimes, though, they’re kind of unbelievable. And, sometimes, they’re downright nauseating. Take, for example, this letter issued on February 19, 2016 to a principal investigator (PI) based in New York. FDA inspectors found him to be in violation of 21 CFR Part 312.62(b), related […]
Deploying Risk-Based Monitoring (RBM) Strategies
In a time when the turnover rate for clinical monitoring positions in the U.S. hovers around 25%, it’s more important than ever to do more with less. With risk-based monitoring (RBM), contract research organizations (CROs) and sponsors can leverage data in existing IT systems to spot, rectify, and prevent issues related to the execution […]
Leveraging Real-World Data To Develop Better Drug Profiles
Real-world data, the data generated about drugs and devices in real-world settings (e.g., routing doctor visits, hospital stays, etc.), can help develop more accurate product profiles. This is because the data comes from products that are no longer confined to the smaller, homogenous populations involved in clinical trials. More comprehensive profiles can help better […]