Posts Tagged ‘Clinical and Safety’

Now that December is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in November – they’re ranked in order of popularity, with number one being the most viewed piece. Top 25 Biotech Companies European […]

This is perhaps the biggest complaint we hear from both sponsors/contract research organizations (CROs) and sites/investigators. Sponsors and CROs dedicate countless resources to researching and addressing payment questions and concerns raised by site personnel, and site personnel often feel frustrated, undervalued, and distrustful of sponsors and CROs that do not pay them as promised. When […]

At first glance, having outdated contact information for sites might seem like a pretty minor issue. But when it results in delays related to required documents, monitoring visits, or clinical supplies, the issue quickly becomes more serious. It might be easy to keep a sponsor or contract research organization (CRO) in the loop when a […]

While sponsors, contract research organizations (CROs), and clinical sites all acknowledge that site monitoring is a necessary part of ensuring clinical trials are run in compliance with governing regulations and protocols, it can be a rather burdensome process, both for monitors and for sites. Monitors struggle with scheduling the visits, having access to everything they […]

Keeping sites in compliance with their required documents is an ongoing battle for every sponsor and contract research organization (CRO). Considering the volume of documentation involved in a clinical trial, it’s no wonder why sites struggle to stay on top of it, or why sponsors and CROs get frustrated when auditors issue findings against them […]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

Now that November is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in October – they’re ranked in order of popularity, with number one being the most viewed piece. Aggregate Report Preparation In Safety […]

Dirty clinical data is one of the most costly aspects of clinical trials. Not only does the review and cleanup slow down time to market and increase development costs, dirty data can stall or even kill a new drug application (NDA). Consistently receiving dirty data from sites can seriously damage a sponsor’s or contract research […]

We are quickly coming up to the go-live of the MedDRA 20.1 dictionary. The new version; maintained by the MSSO was released in September 2017; per regulatory guidance will go live on the first Monday, two months after its release. This version, 20.1 will be live 06Nov2017. Our clients often have questions about upgrading their […]

Even when sites are able to recruit a large pool of potential subjects, sponsors and contract research organizations (CROs) see far too many subjects who fail to pass the screening visit (screen failures) and subjects who pass the screening visit only to leave the study early (early terminations). Because sites get paid for every subject […]

Aggregate report preparation represents one of the single most time- and resource-intensive pharmacovigilance regulatory requirements, which is why many companies are interested in more automated solutions that are fit-for-purpose. What we typically recommend to clients is a focused approach that optimizes as much as their internal workflow as possible. We also recommend that subject matter […]

The FDA has decided that it will update the ciphers for their Electronic Submissions Gateway (ESG), but what does this mean for you? Here is the message that was received: FDA Electronic Submissions Gateway (ESG) will update ciphers and SSL protocols in Production on Saturday, January 20, 2018 at 9:00 PM EST. Please make sure […]