Recently, I had a Siebel Clinical Trial Management System (CTMS) client requirement to load data into the database, clearly the purview of Siebel Enterprise Integration Manager (EIM). The client sent me the data in a spreadsheet, and it looked something like this: Site_Number Contact_ID Role 800,1,300,500 1-2ASW Pharmacist 6,7,2 1-4RSW Doctor 1,2,4,6,7,8 1-5E33 Lead CRA […]
Life Sciences
Innovate Data with Artificial Intelligence (AI) in Healthcare
Artificial intelligence (AI) has established a dominant disruption in transportation, marketing and financial services, among other divisions. In the realm of healthcare, AI is gaining momentum and has the potential to considerably change the industry, from the exam room to the back office to the supply chain. Forrester predicts, “70% of enterprises are anticipated to […]
Key Takeaways About Compliant IT Systems In The Cloud
This is the final post in our series on maintaining regulatory-compliant IT systems in the cloud. In this post, we’ll go over the key takeaways from the series and then we’ll send you on your way! Regardless of how much control you have over your IT systems, if you are using them for regulatory purposes, […]
The Importance of a Digital Strategy for Women’s Health Services
The strategy for women’s health and well-being has been widely discussed at global and domestic levels for many years. With life expectancy remaining higher for women than it has for men, a shift towards prevention and wellness, the rapid adoption of digital technologies improving accessing to a wealth of healthcare information and services at the […]
Tips And Best Practices For Compliance In The Cloud
As we’ve learned in the previous posts in this series, having a thoughtful, thorough cloud vendor qualification process and intelligent SLAs in your cloud vendor contracts will help you maximize the value of the cloud while maintaining regulatory compliance. In addition, here are some tips and best practices to help you knock it out of […]
Why Aren’t Any Business Intelligence Apps Using Graph Data
Business intelligence isn’t always about the facts. Don’t get me wrong, there will always be a place for dashboards and BI reports. Making business decisions without them is unimaginable so we all appreciate SQL based business intelligence systems with star schemas that point to meaningful fact values. One of the many lessons learned from the […]
Data Lake as Aggregator – The Critical Role of the Catalog
My previous blog talked about a Data Lake using a Supplier-Aggregator-Consumer analogy and talking about the roles each of these parties play. One factor that is critical to the success of this approach is the use of a common vocabulary that ensures efficiency and effectiveness in the interactions and collaborations between the parties. The implication […]
How To Use Contracts For Regulatory Compliance Of Cloud Systems
In my previous post in this series, we discussed how to qualify cloud vendors. Once that process is complete, the second step to maintaining compliance is to document your specific regulatory requirements in a contract with the cloud vendor, usually in the form of service-level agreements (SLAs). In this blog post, I include a range […]
Argus Safety, Oracle Clinical & RDC Release Notes [July 2018]
Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, including: Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Generally speaking, we review release notes at the beginning of each month for the previous month. On occasion, there are no new releases and, therefore, nothing to […]
How To Qualify Cloud Vendors
We recently completed a 21 CFR Part 11 gap analysis engagement for a client that was largely using SaaS applications, but had no cloud vendor qualification process in place. They had just been allowing each business unit to select the applications that met its user requirements, accept whatever validation documentation the cloud vendor supplied (if […]
Who Is Responsible For The Compliance Of Cloud Systems?
Any time you take advantage of a cloud service – infrastructure, platform, or software – for a regulated purpose, you are ultimately responsible for its regulatory compliance, not the cloud vendor. This is critical for you to remember. So, how can you ensure regulatory compliance of a software system you did not build, you do […]
Guidance For Early Adopters Of The TransCelerate SIP
In today’s post, the sixth in the series on the TransCelerate Shared Investigator Platform (SIP), we offer guidance and best practices for early adopters of the SIP. For more background information on TransCelreate or the SIP, or for guidance directed toward companies that have not joined TransCelerate or adopted the SIP, see the previous posts. […]