Life Sciences | Monitoring the Pulse of the Life Sciences Industry
Blogs

Life Sciences

Monitoring the Pulse of the Life Sciences Industry

MedDRA Upgrades: 4 Clarifications

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 […]

Read more

How To Fix Ineffective Subject Screening At Clinical Sites

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 […]

Read more

6 Applications And 1 Real-Life Example Of IoT In Life Sciences

I recall hearing Michael Farrell, the CEO of ResMed, speak about how important the Internet of Things (IoT) is to his company. There’s probably not a better case study of IoT in life sciences than ResMed. The medical device company specializes in sleep apnea products and solutions. They also happen to be the makers of […]

Read more

How To Configure Constrained Picklists In Siebel

A common requirement in Siebel is to configure constrained picklists. First, let’s define what a constrained pick list means. A constrained picklist is a list of values (LOV), in which the values are dependent on another field. Say we have an applet that has two fields: medical type and medical product. These are the values […]

Read more

Aggregate Report Preparation In Safety And Pharmacovigilance

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 […]

Read more

Incoming Novartis CEO Looks To Disney For Inspiration

On September 4, 2017, Novartis announced that its current CEO, Joseph Jimenez, will step down from his role in February 2018. He will be replaced by Dr. Vasant Narasimhan, the company’s current global head of drug development and chief medical officer. The backgrounds of the two executives couldn’t be starker. Mr. Jiminez has very little […]

Read more

FDA Ciphers Update: What To Consider If You Have Argus Safety

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 […]

Read more

How To Fix Slow Subject Recruitment At Clinical Sites

Even the most promising clinical sites can have trouble recruiting enough eligible subjects. Pressure from upper management and/or the sponsor organization to meet recruitment targets causes stress and anxiety for study managers, which in turns strains their relationships with underperforming sites. This tension can be alleviated by helping sites: Broaden their pool of potential subjects […]

Read more

Oracle Clinical 5.2 Released: 7 Changes To Know

It’s been almost two years since I wrote that Oracle Clinical and Oracle Remote Data Capture (RDC) 5.1 was released. Well, today I can say that 5.2 has been released and is available to anyone who is looking to upgrade. While 5.2 is not considered a major release, it is an important one, as it […]

Read more

7 Ways To Fix Your Relationships With Clinical Sites

In our nearly 20 years of working with the life sciences industry, we’ve spoken with countless pharmaceutical, medical device, and contract research organizations (CROs) about their relationships with clinical sites and investigators. We’ve listened to their struggles and the things they’ve done to try to make things better, including what’s worked and what hasn’t. We’ve […]

Read more

Perficient Life Sciences

We monitor the pulse of the life sciences industry, from clinical to digital. Read about the trends, insights, successes, warnings, and solutions that move science forward.

Archives