In our last “cloud fact or fiction” post, we discussed the ability to migrate clinical and pharmacovigilance data to the cloud. Let’s jump right in and talk about system integrations in the cloud. Claim #7: Clinical trial software in the cloud cannot be integrated with other systems.
Regulatory Compliance
Are Hosted Systems Open Or Closed Under 21 CFR Part 11?
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: When Argus is hosted by Perficient, is it considered an open or closed system for the company that contracted Perficient to host?
Even For Charity, EU Drug Makers Obligated To Report AEs
Pharmaceutical companies often donate their products to those in dire need, but it hasn’t been especially clear how adverse events for donated products should be handled. In light of recent public health programs to fight neglected tropical diseases, the World Health Organization (WHO) asked the European Medicines Agency (EMA) to clarify the marketing authorization […]
Regulatory Reporting Rules In Argus Safety
In Argus Safety, all of the parameters for configuring the worldwide regulatory reporting rules are clearly identified on a single administration screen. You have the capability of selecting various case or event-level attributes, as well as using very advanced conditions, to focus the automated triggering of these report rules in various circumstances.
21 CFR Part 11: There’s Still Time To Get Your Decoder Ring
Inspired by our blog series from earlier this year, the head of our Computer System Validation team will be delivering a webinar on Thursday, April 23, 2015 aimed at “decoding” the 21 CFR Part 11 regulation. In the webinar, validation guru Sally Miranker will be reviewing the regulation point by point, offering up Perficient’s interpretation […]
SIFMA AML Highlights: Compliance, Enforcement and Preparing for Tomorrow
We attended SIFMA’s Anti-Money Laundering & Financial Crimes Conference last month where experts in the industry discussed legal and regulatory developments, enforcements, and industry perspectives. There were many discussions around whistleblowers, anti-bribery & corruption, securities fraud and even marijuana related securities legislation. Andrew J. Ceresney, Director of Enforcement at the U.S. Securities and Exchange Commission, gave a […]
21 CFR Part 11 Decoded: Signature/Record Linking
This is the final post in the 21 CFR Part 11 “mini-series” on Subpart B – Electronic Records. The last Section in Subpart B is 11.70 – Signature/Record Linking. In the table below, the actual language from each regulation is on the left, and my personal interpretation of what that language means is on […]
When Supplement Manufacturers, Not Athletes, Cheat
A recent article in Forbes reported that an astounding percentage of dietary supplements do not contain the main ingredient listed on the label. That’s concerning, considering there aren’t too many stringent regulations they have to follow, unlike pharmaceutical companies.
21 CFR Part 11 Decoded: Controls For Open Systems
This post is the second in the 21 CFR Part 11 “mini-series” focused on Subpart B – Electronic Records. Pull out your decoder rings and let’s look at Section 11.30 – Controls for Open Systems. In the table below, the actual language from each regulation is on the left, and my personal interpretation of […]
The Health Information Exchange (HIE) Teeter-Totter
The cyber-attack on Anthem, the nation’s second-largest health insurer, directly reflects the vulnerability of healthcare organizations, which are years behind other industries in regards to protecting personal information. In today’s healthcare industry, the federal government encourages sharing information across the continuum, which is critical to improving patient care. The challenge is the balancing act between […]
2 Questions To Ask When Deciding Whether To Validate Your CTMS
As a company who implements and enhances clinical trial management systems (CTMS), a question we hear a lot is, “Do we need to validate our CTMS?” And, to be honest, it’s one we continue to debate internally. Why is the answer not black and white? Well, our internal debate always works its way back to […]
This Is Bad News For Sponsors And CROs
In a recent post, I wrote how not giving principal investigators (PIs) the right systems (i.e., investigator portals) can lead to frustration, causing them to eventually withdraw from studies. Apparently, times are still rough for PIs and investigator sites. According to a new Tufts CSDD Impact Report and Wall Street Journal article, while the […]