Digital transformation is a term that is being thrown around quite a bit in every industry and sector. But it is frequently misunderstood or misrepresented. Companies are trying to stay relevant and current by adopting specific new technologies to claim their move towards digital transformation. But it is much more than simply using new technology. […]
Param Singh
Param Singh has been working in the life sciences industry his entire career. As the director of clinical trial management solutions at Perficient, he developed the clinical trial management team to become one of the best in the industry. Param leads a highly skilled team of implementation specialists and continues to build lasting relationships with clients. He has a knack for resource and project management, which allows clients to achieve success. Param has been with Perficient, via the acquisition of BioPharm Systems, since 2008. Prior to joining the company, he guided the clinical trial management group at Accenture.
Blogs from this Author
How Can AI Be Used For Clinical Trials?
The continuous innovation of technology is changing the way companies operate across different sectors. In particular, big data and artificial intelligence (AI) are expected to have the most significant impact. In this post, we’ll discuss how big data and AI can be used to support clinical trials in a variety of ways. How does big […]
Implementation of Siebel CTMS in the Oracle Cloud: Session Recap
Yesterday, I was fortunate to have been able to present with Pfizer at Oracle Health Sciences Connect 2019 on Perficient’s implementation of Oracle’s Siebel Clinical Trial Management Systems (CTMS) in the Oracle Cloud for the company. On stage at @OracleHealthSci Connect with @pfizer, discussing our implementation of #Siebel CTMS in the #Oracle #Cloud for the […]
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, […]
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 […]
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 […]
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. […]
Cloud-Hosted Terminology: Types Of Systems
As we continue our series on maintaining regulatory-compliant cloud systems, let’s touch on a few key terms. Below are explanations of the primary cloud-hosted offerings available in the market. Infrastructure-as-a-Service (IaaS) When you purchase a software system and opt to have a vendor host it for you instead of installing it on servers you own, […]
Guidance On Whether The TransCelerate SIP Is Right For You
This is the fifth post in a series on the TransCelerate Shared Investigator Platform (SIP). For more background, including benefits and challenges, see the previous posts. For those of you who have not yet joined TransCelerate, or who have joined but have not yet adopted the SIP, here are some ideas to consider in your […]
Using Digital Technology In Post-Market And Real-World Contexts
Digital technology has applications throughout clinical studies, from recruitment through data collection. But, it is also being used in exciting and meaningful ways once a drug or device has gone to market, both to improve patient outcomes and to keep sponsors informed. Below are a couple of examples. Huggable, a teddy bear developed by Dr. […]