At the ClinTech conference this year, I was excited to hear industry leaders discuss how next-generation technologies are helping them transform their businesses. In fact, implementing a “transformational” technology was one of Lisa Rakebrand of Janssen’s explicit directives for the organization’s selection of a new eTMF application. “A case for radical change is driven by both internal and external perspectives,” noted Rakebrand in her presentation.
Posted by Jen Goldsmith on Monday, April 21, 2014
Posted by Dharma Subramanian on Friday, April 4, 2014
This year, the conclusion of the NCAA March Madness tournament is not the only anticipated event on the calendar. The life sciences industry has a buzzer beater of its own with the first round of data submissions due under the Physician Payments Sunshine Act. Correctly aligning the right NPIs with the right individuals and organizations has an important bearing on the quality of the reports being submitted.
Posted by Ted Wallach on Friday, March 7, 2014
A great user experience (UX) is vital to the success of an application in the life sciences industry. A better user experience results in faster training, increased adoption rates, higher user satisfaction – and ultimately, better productivity. Among the many advantages of multitenancy, the user experience is also better in a true multitenant cloud application. Here’s a closer look at why.
Posted by matt.wallach on Friday, February 21, 2014
IDC Health Insights’ annual Top Preferred Life Science Technology Vendors report just released provides a look at where the industry is heading in 2014. The latest rankings for software spending planned for 2014 show that cloud adoption is rapidly growing. Veeva, the only industry cloud provider on the list, was also the sole company to increase its position in the ranks – placing fourth overall in the software category.
Posted by Carol Jacobson on Wednesday, February 19, 2014
Closed loop marketing (CLM) has gotten a second life with the upsurge of technological innovations over the last decade. In a 2008 survey, only about 25 percent of pharmaceutical companies said they were engaged in “full-blown closed loop marketing.” Over the last six years, we’ve seen several companies leverage industry innovations, including combined CRM and CLM, to revitalize customer engagement. Here are some best practices to help you as you look ahead.
Posted by Dan Goldsmith on Tuesday, February 4, 2014
Every company needs accurate customer profiles, and most use services or tools to clean addresses—making sure that zip codes are filled in and street names are spelled correctly, for instance, ensuring that the customer data is usable. While such tactics might help with more efficient sales and marketing execution for the short term, they don’t offer companies a way to adapt to what is a rapidly changing landscape.
Posted by Bob Kenney on Monday, January 13, 2014
Imagine, the health authority is on-site and the inspector asks for your document change control procedure. It’s a robust process, but does your organization follow it? Do you have the necessary records to prove it? FDA warning letters show that companies are frequently cited for deficiencies in their documentation change control procedures.
Managing change to your company’s quality system documentation can be daunting. Deviations, out of specification test results, audit findings, complaints and many other factors create a constant state of flux. Controlling and chronicling those changes is critical for product quality and compliance with health authority regulations. The penalty for not following through can lead to fines, product recalls, or facility shutdowns.
The change control feature included in the latest release of Veeva Vault QualityDocs, enables companies to fully control quality system documentation changes, reducing the risk of non-compliance.
Posted by Todd Tullis on Monday, December 30, 2013
Site start-up is one of the most hectic periods in clinical trials due to the sheer volume of work involved and the pressure to get sites initiated quickly. Simplifying communication with sites can greatly reduce the strain associated with this critical phase. The latest release of Vault eTMF contains a new feature called “document packages” that helps identify the relevant documents and deliver them to sites, speeding up site activation and returning valuable time to trial managers.
Posted by Peter Lammers on Friday, December 27, 2013
At its crux, multichannel is about creating a seamless, integrated experience for customers. Consumers expect information on demand, and the life sciences industry is no exception. Healthcare professionals, pharmacists, and payers want pharma to deliver relevant information and services that they want, when and how they want it delivered. Today, any number of communication methods is available – customers could receive information on their smart phone or tablet, via the web, through a call center, from a rep in-person, or some combination of channels.
Posted by Todd Tullis on Wednesday, December 18, 2013
Have you heard of Nadia Bracken’s ClinOps Toolkit blog? It is a comprehensive, growing resource for clinical operations content and perspective. Nadia is an energetic champion for improving patient lives through sharing ideas and practices among clinical development professionals. Her meetup group is a great way to connect with other clinical research professionals in the Bay Area.
Posted by Kate Wilber on Wednesday, December 18, 2013
Key opinion leaders (KOLs) look to medical science liaisons (MSLs) for a deeper understanding of how a drug will help patients, whether it’s already available on the market or pending regulatory approval. But lengthy face-to-face conversations – long the industry’s typical method for communicating with physicians – are increasingly difficult to secure. And according to Center Watch, KOLs want and need more transparent and comprehensive information than what an MSL can provide during one-on-one meetings.
Posted by Jing To on Tuesday, November 26, 2013
Being in the cloud means new innovations come sooner – it has only been four months since our last release! In this blog, we outline the top 10 reasons why Vault 7 will make your life better. This latest release significantly improves end-user experience and automates more business processes, increasing productivity and mitigating compliance risk. With new visibility into a document’s history, intelligent workflows, and easier ways to add and find content, Vault is redefining secure document collaboration.
Posted by Dan Goldsmith on Monday, November 18, 2013
I was fortunate enough to moderate a panel of experts recently to discuss the impact of the ‘network effect’ on the life sciences industry.
What is the network effect? Simply put, it takes place when the value of a product or service increases as more companies participate in the network. For the life sciences, the ‘network effect’ occurs when updates to HCO, HCP, and affiliations data from companies brought together in the cloud are crowdsourced to create a single, trusted, and reliable shared database. Over time, as the user base grows, the data gets better and better. According to industry leaders, this has the potential to transform the way life sciences companies operate.
Posted by Lizette Byer on Friday, November 15, 2013
Even before Microsoft officially released Windows 8, Veeva received interest from customers who wanted Veeva CRM and CLM on the touch-based Windows 8 ‘Modern UI’ platform. By far, the most common reason is the desire for a single-device solution. For IT organizations already familiar with Microsoft infrastructure products, this means supporting a single operating system and fewer devices, as well as easier deployments.
Posted by Todd Tullis on Thursday, November 7, 2013
Progressive organizations are quickly moving toward electronic systems, especially in clinical operations – for good reason. Electronic TMFs help eliminate the inefficiencies and complications associated with paper trials, but many clinical teams stop short of a full transformation. Instead, they simply layer an electronic system over paper processes. Going a level further and completely eliminating paper can deliver more dramatic benefits across clinical development.
Posted by Todd Tullis on Thursday, October 31, 2013
Ken Getz got Veeva’s Clinical Roundtable off to an exciting start by revealing some unexpected data that showed that today’s “alliance partnerships” may not be measuring up to the high expectations of either sponsors or CROs.
Companies cannot afford the burdens of outdated processes
Posted by Mike Burton on Tuesday, October 8, 2013
Anyone who has ever been involved in conducting a clinical trial knows that there is no shortage of hassle and complexity involved. For sponsors and CROs the process often includes collaborating with external CROs and ensuring compliance with a myriad of global regulations. In order to remain compliant, life sciences companies and their partners must be able to keep careful track of an overwhelming amount of data and documents.
Companies need to leverage new technology to create true partnerships
Posted by Jen Goldsmith on Friday, October 4, 2013
At Veeva’s clinical roundtable event last week, representatives from 33 companies, including CROs, sponsors, and stakeholders from across the spectrum of clinical trials, came together with industry thought leaders in Philadelphia for an open, exciting dialogue. With our clinical roundtable, we wanted to provide a frank discussion about the dynamics of clinical trials, and how to harness the strategic value of the electronic Trial Master File (eTMF) in order to drive better operational efficiency, as well as previously inaccessible strategic insights.
5 Simple Checks for No-Hassle Software Enhancements
Posted by steve.harper on Friday, May 3, 2013
One of the biggest advantages of operating on a multitenant cloud is that the software can be continually improved through automatic updates. But how exactly are they deployed? Does a customer have to accept all of the changes? How do you make sure you’re in the know on the vendor side of things? Here are some steps to take to ensure updates to multitenant software go smoothly.
Overly-complex software must give way to technology that’s easy to use
Posted by brittany.machion on Tuesday, March 19, 2013
Life sciences companies often go through extraordinary measures to ensure their content is secure. They can provide customized laptops with strict parameters around downloading or set up complicated VPNs for remote access. But often, they miss a key security hole: their own people.
Posted by Lauren Calabrese on Wednesday, March 13, 2013
Sales reps are a huge asset for pharma companies. In the US alone pharmaceutical companies spend nearly $15 billion a year just on reps! They represent the lion share of the total amount promotional spend, but are pharma companies getting all they can out of this investment?
With the cloud, eTMFs have the potential to revolutionize clinical trials management
Posted by Jay Smith on Thursday, March 7, 2013
As Mike Burton recently posted to our Medidata blog, Geeks Talk Clinical, paper is often the very last thing both sites and sponsors think about during a clinical trial. How times have changed. Not so very long ago, paper used to completely drive the clinical process — and in many trials, it still does.
Why would you ever want to see a folder again?
Posted by Rik Van Mol on Tuesday, February 26, 2013
Now, it is not really a strange question because people are used to doing things in a certain way simply because it’s the way it’s always been done. Using folders is a great example of this. Look at traditional document management systems — they use cabinets and folders because they mimic how physical paper has been managed for hundreds of years. Using folders kind of worked, until that is, end-users started to really struggle with poorly structured information repositories.
A successful CRM deployment involves multiple steps and precise attention to detail.
Posted by Nathan Chestney-Stagg on Tuesday, February 19, 2013
I want to start with a confession. When I was considering the subject of this post, I arrived at the 20 most important aspects of CRM deployment. But 20 of anything is overwhelming, especially in a blog post, don’t you think?
So I decided to cut down to 10, then quickly realized that I had a problem with that also. Ten seems to suggest a completeness which I am not comfortable with. It suggests I have the perfect answer and as my wife will tell you, that’s rarely true. After all this I thought nine. Yes, nine of the most important aspects of deployment and I’ll leave space for any others that you feel are most important to you.
In this blog post, we’ll take a look at dashboards, a powerful new feature released with V5 of Veeva Vault.
Posted by George Lee on Monday, February 11, 2013
You can now create easy-to-read, graphic dashboards that provide real-time answers to important questions. Because dashboards are built on top of reports, you can bring together key performance metrics from different reports onto a single dashboard page to gain at-a-glance insight. When you run a dashboard, Vault runs the underlying reports in real time so you can see the latest metrics.
Cloud-based software companies can execute a validation process that is just as thorough – if not more – than that of on-premise software.
Posted by steve.harper on Wednesday, January 16, 2013
Validation means different things depending on whom you talk to, but one thing’s certain: it’s a necessity for a regulated content management system, particularly for the life sciences industry. Content that needs robust audit trails and strict security parameters also needs to be housed in a validated environment. To ensure compliance, traditional content management implementations will go through a rigorous validation process to ensure they are validated.
Security and Compliance Are Main Focuses for Companies Big and Small
Posted by brittany.machion on Tuesday, November 20, 2012
In the recent AIIM Industry Report, almost half of the responders believe that document and content management applications will be cloud by choice within three years. But the study also reports an oft-cited conflict between business users and IT staff: users want to share content easily with external partners, while IT is keen to keep it controlled.
And not an exercise in marketing buzzwords
Posted by brittany.machion on Wednesday, October 24, 2012
We’re right in the middle of fall tradeshow season, and with more and more people talking about the cloud, sometimes it easy to get bogged down in buzzwords. Companies, knowing how lucrative the cloud can be, have coined all kinds of confusing terms to describe the cloud in order to suit them (private on-site cloud, hybrid cloud, shared private cloud, etc.). But the reality is, none of those terms really matter.
With a SaaS implementation, life sciences companies spend more time using their technology instead of preparing for it.
Posted by howard.hsueh on Wednesday, September 5, 2012
I’m sure we’ve all experienced this: You hear about the hottest new toy and bring it home, only to discover upon opening the box that: A.) It looks nothing like the picture on the box (all the cool thingamabobs in the picture are sold separately), B.) Batteries are not included, and C.) “Some assembly required” is a HUGE understatement. By the time you find the right batteries, buy all the extra thingamabobs, and finally figure out how to assemble the darn thing, several days will have passed and the toy *still* won’t look like the picture on the box.
Sounds familiar? It sounds a lot like some of the on-premise software implementations I’ve been a part of.
SaaS simplifies training, meaning happier end-users and better business processes
Posted by melissa.aron on Tuesday, July 31, 2012
There are plenty of virtues around Software-as-a-Service (SaaS) – rapid deployment, low-maintenance, free upgrades, easy configuration, etc. But an often overlooked benefit is how SaaS solutions simplify the training for new users. In the past, when it’s time to get the teams on board, they aren’t usually psyched for training. Mammoth user manuals, days and days learning to search and file correctly – it’s no wonder eyes gloss over.
Cloud-Based Solutions Are Key for Life Sciences Global Advertising and Promotional Content
Posted by damian.kelly on Wednesday, May 30, 2012
As a consultant in the life sciences industry for over 10 years, one of the most striking developments in content management has been the shift from “wouldn’t it be great if we could do this globally” to “we need to do this globally.” In particular, managing advertising and promotional content has become a major pain point. While opportunities in emerging markets like China and Brazil are exploding, life sciences companies are often struggling to keep up. Why?
SaaS solutions turn the traditional on-premise model upside down
Posted by eric.makovsky on Wednesday, February 29, 2012
Buying on-premise software is like buying a new car. When you first get it, you have the latest features, a brand new engine, top line performance, even that “new car smell.” However, it seems as soon as you drive it off the lot it starts to depreciate: wear and tear occurs and newer models roll out. Remember when having a CD player in a car was all the rage? That is, until you needed a USB port to plug in your iPhone to access your music library.
On-premise systems and private clouds just don’t cut it
Posted by Jen Goldsmith on Thursday, January 26, 2012
Ask life sciences companies what questions they have about moving their content to the cloud and you will likely find at least one “security” related question. Indeed, this is an important topic, and it is vital that organizations address content management security at all levels, particularly when managing highly sensitive life sciences information, such as R&D or manufacturing information. Interestingly, there are still some who maintain that data is only safe if you store and maintain it in your own data center(s), not when it’s “floating around” in the cloud. This inaccurate – though entertaining – description of the cloud (we’ve never seen floating data), ignores the fact that data can be even more secure in the cloud, particularly when working in the regulated cloud
Veeva Vault Will Continue to Blaze the Trail in 2012
Posted by Jen Goldsmith on Tuesday, January 3, 2012
Last year was one exciting ride for the Vault team. Now that 2012 has begun, it’s astounding to think about how much has been accomplished in a little under a year. Just this past February, we were at DIA’s EDM conference announcing our new content management product, Veeva Vault. Interest continued to grow throughout the summer as we signed our first customers and began their implementations.
Are you sharing regulated content seamlessly -- and compliantly?
Posted by Jen Goldsmith on Tuesday, November 29, 2011
The Real Story Group, a CMS research and evaluation site, details the two main types of document management systems: transactional (think medical claims processing) and collaborative (such as those that manage submission documents for the life sciences industry). Indeed, collaboration is essential for life sciences companies today. Unlike in years past when most work was done in-house, organizations are now increasingly relying on partners and vendors to assist them with the intricate process of bringing a drug to market. Therefore, it’s essential that teams are able to work together seamlessly — and compliantly — to get the job done.
End-to-End Promotional Materials Management for Life Sciences
Posted by Jen Goldsmith on Thursday, October 20, 2011
It’s been a tremendous year for Veeva Vault. In February, we announced that we would be creating the Veeva Vault product and Vault PromoMats application. By June of this year, we had a full cadre of early customers focused on implementing Vault to support critical business needs. And just a few months later, on Tuesday, October 18th, we announced the general availability ofVault PromoMats, the life sciences industry’s first end-to-end promotional materials management solution. To celebrate, we welcomed customers, partners, industry thought leaders, and press to an official launch event at the Loews Philadelphia hotel.
And 4 Ways to Fix It
Posted by Jen Goldsmith on Tuesday, September 13, 2011
Last post, I wrote about a clinical study project manager whose role had been reduced to nothing more than that of a document hunter. Instead of developing new and innovative means of study report creation, or paving the way for multimedia report review capabilities, she was spending 90% of her time just looking for documents. In my post I explained how life sciences companies got into this mess. The question now is, how do we fix it?
And 4 reasons document management system users feel stuck
Posted by Jen Goldsmith on Wednesday, July 20, 2011
I was talking with a client the other day and asked her what her greatest challenge was in producing her clinical study reports. As a seasoned document management user from a Top 10 pharma organization with document management systems in place since the mid-90’s, I expected her answer to be something like “automatic generation of study report structures,” “intelligent hyperlinking” or “component authoring” – all hot topics in the world of Life Sciences advanced document management. Her answer, however, startled me: “Finding the documents that I need. Today, I am nothing more than a document hunter.”
3 Signs Your "SaaS" is Not What You Thought It Was
Posted by Jen Goldsmith on Tuesday, May 24, 2011
Have you heard about Software-as-a-Service (SaaS)? If not, hundreds of vendors are eager to tell you about it. SaaS is so popular – Forrester predicts that SaaS revenues will reach $92.8 billion by 2016 – that many vendors are angling every day to find out how they can get a piece of the action. Because of this tremendous growth potential, and because there’s such confusion around what SaaS actually is, some companies will swear up and down that they provide a SaaS-based solution, when really what they do is add up what it costs them to host the hardware, install and configure the software, and maintain the environments. Then they divide this total cost by the number of months in your contract (typically 3-5 years) and by the number of users. Voila! Per user pricing and not in your data center. This must be Software-as-a-Service, right? Wrong.
What would you do with a blank canvas?
Posted by Kate Wilber on Monday, April 11, 2011
Remember those days in elementary school when you were handed a blank sheet of construction paper and a pile of crayons? Some of your classmates had a formula – green grass on the bottom of the page, semi-circle of sun in the upper corner, a mixture of flowers – scenes they had seen again and again. Others seemed to dive in, unconstrained by rules, and come up with something wildly different to showcase on the refrigerator.
3 tips for better regulated document tracking practices.
Posted by Jen Goldsmith on Wednesday, March 2, 2011
As content management professionals in a regulated industry, we often focus on what it takes to get documents drafted, reviewed, updated, and, ultimately, approved. We gather metrics, tweak our methods, and redefine our processes all in an effort to increase throughput, enhance quality, and reduce document costs. And this is important – very important – because each year the amount of digital content being created increases significantly, a trend that drives additional cost and complexity into content management processes. Just look at life sciences promotional content. In the last 10 years, the number of promotional pieces that the US Division of Drug Marketing, Advertising and Communications (DDMAC) reviews on an annual basis has more than doubled from about 38,000 pieces in 2000 to more than 79,000 pieces in 2010.
Posted by Jen Goldsmith on Wednesday, February 2, 2011
Fifteen years ago, before I started working with content management systems, I was a frustrated author with a bachelor’s degree in clinical psychology and a penchant for art and archaeology. I’d left my job as the Director of Marketing for a small, allied health book publisher in Philadelphia and decided that I needed to do something new and different – Information Technology. Fresh from IT consultant boot camp, I waited anxiously for my first assignment. At last, the phone call came. I was going to work for Jantzen. I explained to my friends and family that I was going to support IT systems for a manufacturer of leotards and swimsuits. Boy, was I wrong.