Posts Tagged ‘clinical trials’

Now that October 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 September – they’re ranked in order of popularity, with number one being the most viewed piece. An Insider’s Look At If And When […]

Recently, we had a client who wanted to import contacts into their Siebel CTMS, which uses a moderately modified version of Innovation Pack 2013 (a.k.a. version 8.1.1.11). The contact data was stored in a spreadsheet and looked something like this: Last Name First Name Street Address City Postal Code Country Flinstone Fred 100 Rubble Ln […]

It seems every company in every industry is talking about “going digital.” But, what does that really mean? At its heart, going digital is really just about relationships: relationships with customers, partners, team members, and the world at large. Since the introduction of mobile and digital technology, the ways in which we interact with others […]

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 Accel-Account Manager Accel-Copy ASCEND (Siebel CTMS) Generally speaking, […]

The satellites are finally in orbit! In Oracle’s innovation pack 2016 (IP2016) for Siebel Clinical, they introduced a new feature that allows clinical sites to have satellite sites organized beneath them. Here are some highlights of the satellite site feature: Multiple satellite sites can be defined for an individual parent site Parent site data defaults […]

Study managers, rejoice! In Oracle’s innovation pack 2016 (IP2016) for Siebel Clinical, Oracle introduced a new feature that allows subjects who are enrolled at one site to be transferred to another – without losing any history. Here are some highlights of the subject transfer feature: Ability to transfer subjects from one site to another within […]

In the European Union, the use of E2B(R3), along with IDMP, is in legislation, so not complying by the deadline could have legal repercussions. Non-compliance with the FDA and MHLW’s requirements could also bring unwanted scrutiny. More importantly, if an organization does not comply by the deadlines, they will not be able to send ICSRs […]

Yes, some validated systems can comply with E2B(R3). With respect to Oracle Argus Safety, the current version, 8.0.1, is able to comply with E2B(R3), Electronic Vaccine Adverse Event Reporting System (eVAERS), and Electronic Medical Device Reporting (eMDR) reporting requirements. If a company is simply looking to meet E2B(R3) requirements, we advise waiting to upgrade until […]

At this year’s MedCity CONVERGE, a two-day summit in which executives convene to discuss the future of innovation in healthcare and life sciences, digital was a hot topic. In a presentation titled “Digital Health’s Arrival (Or Not) In Pharma,” Dr. Naomi Fried, an expert on digital health innovation and past chief innovation officer at Boston […]

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 Accel-Account Manager Accel-Copy ASCEND (Siebel CTMS) Generally speaking, […]

Now that August 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 July – they’re ranked in order of popularity, with number one being the most viewed piece. When Do Companies Have To […]

The issue is not the type of system used to collect adverse event data, but rather how the data is submitted to the FDA, EMA, and MHLW. If an organization is using spreadsheets to collect safety data or is unable to transmit data via E2B, it will have to report the data via a web-based […]