A message from the President

To our IRMS community,

As we begin our 33rd year in business, I want to express my appreciation for the continued confidence you place in us. 2015 was a very busy year for us with many new clients and a record amount of upgrades and client focused services. 2016 promises to be even bigger and better.

There has been a significant shift in the implementation of the IRMS software. A majority of our new clients and prospects have decided to take advantage of the OBA cloud. Thus reducing the burden on their IT staff as well as eliminating the hardware requirements for a traditional on premise installation. We’ve made a significant investment in the infrastructure necessary to support this shift.

Most importantly, we realize how important excellent customer service is to you. We will always strive to improve our service in all aspects of our relationship with you. From installation, configuration, validation, and ongoing support, OBA will make its best efforts to provide consistent and excellent service.



Dennis Oles: Founder and President of Online Business Applications.

Safe Harbor Agreement between U.S.and EU is
NO LONGER VALID

The Court of Justice of the European Union ("ECJ") put out a decision on October 6, 2015, declaring that the “U.S.-EU Safe Harbor Framework” is no longer a valid way to ensure an adequate level of protection when transferring personal data from the EU to the United States.

Below we will provide a brief overview of what OBA is doing to ensure our EU and EEA clients can continue to use the OBA Hosted Service while complying with EU Data Privacy regulations.

First of all, WHAT IS THIS SAFE HARBOR AGREEMENT??

The Safe Harbor agreement basically allows U.S companies to transfer EU company and citizens’ data to the US. This would only be a valid agreement if the place it was being sent was protected under EU standards. In the past there has been a self-certification process that companies like Facebook®, Google®, OBA, Inc, and thousands of companies operating in the EU, would go through, promising that the EU data that is being stored in the US would be protected.

WHAT DOES THAT HAVE TO DO WITH US??

Well, in order for OBA to host client data from multiple divisions, this self-certification became necessary, which has been a part of OBA internal compliance since the inception of our hosting solution. If you are a client of OBA that is hosted, and has or is planning to have data from multiple divisions, then you are subject to this compliance requirement.

WHY IS THE AGREEMENT “INVALID”??

In the wake of the U.S. surveillance revelations by former National Security Agency (NSA) contractor Edward Snowden, Austrian student Max Schrems filed a complaint against Facebook to the Irish data protection authority. He claimed that Snowden's leaks showed Facebook wasn't sufficiently protecting user data as the NSA was carrying out mass surveillance on technology companies. His complaint was thrown out by the Irish data protection authority, and when Schrems appealed to an Irish court, it was sent to the ECJ. The EU's top court said the Safe Harbor agreement was invalid as U.S. public authorities could access the data and individuals had no means of redress for misused data, among several other reasons. Facebook has repeatedly denied that it allows backdoor access of its user data to spy agencies.

WHAT ARE US TECH FIRMS AND OBA, Inc. SAYING ABOUT THIS?

US Tech firms do not seem to concerned and continue to operate under a “business as usual” mandate. OBA has taken steps to include an appendix to all Master Service Agreements with our clients that include the EU model clauses for Personally Identifiable Information. This will further ensure that all of our clients’ data transfers are secure, and comply with all EU data transfer clauses.

Please contact our Director of Operations, James Koursaris at james.koursaris@irmsonline.com if you have any further questions or would like a copy of our MSA appendix for your legal review.

WHATS NEXT??

The EU and U.S. are working on a new Safe Harbor agreement, which has been in the pipeline for around two years. Europe has been trying to restrict U.S. government access to EU citizens' data and is pushing for provisions that let Europeans sue U.S. companies in their own courts if their data are misused. The ITIF has urged the U.S. government to put in place measures to placate the EU. "The updated agreement should reflect the EU request that a national security exception is used only to the extent that it is strictly necessary and proportionate for a given incident," the ITIF said in a statement. But the ECJ ruling is likely to have strained tensions between the EU and U.S.

IRMS Workshop 2015 - Review

IRMS Users gathered in Downtown Chicago this past September to partake in OBA’s Annual User Workshop.

The Radisson Blu Auqa Hotel, steps away from Navy Pier, served as the venue, marking the second year the Workshop was held in the Windy City, as 43 participants from 20 different companies attended the two-day event.

2015 marked the 19th year OBA hosted its annual event and the 29th Workshop of its kind.

“We care about the future of IRMS, and engaging our clients by listening to their needs and suggestions are necessary components to ensuring IRMS continues to meet the ever-changing requirements of our industry.”
- Dennis Oles, OBA President



Although some fun was had, as OBA hosted a dinner cruise the first night of the event, those that put the Workshop agenda together ensured content and interaction was center stage.

Day One started with a showcase of IRMS 6, OBA’s newest Medical Information Request Management System, as session facilitators provided a demonstration of standard request case process flow, while engaging attendees in the efficiencies IRMS 6 now offers.

The remainder of the Workshop provided sessions, often broken into different tracks, based on CM Workflow, Global Deployments, Querying and Reporting and other topics relating to configurations and administration to help users deal with the day to day challenges facing the Medical Information community.

Another exciting change to the format was creating more collaborative sessions. John Ferguson, OBA’s Director of Client Services, wanted to make it more interactive, ensuring the true value of the sessions were achieved.

“I wanted a workshop that facilitated conversations. An eight-hour lecture is not a workshop and I believe we succeeded in making it more conducive to learning.” - John Ferguson, leader of the Workshop Committee.



Plans are coming together for the 2016 Workshop, and OBA expects to host it in again in late summer/early fall in Chicago.

“As a software developer, I’ve attended many workshops provided by various software vendors,” said Oles, reflecting on the importance of the Workshop, “and in my opinion they have been educational as well as social. I want to continue providing education, technical support, and a social experience to our users. It is still the best place to learn about new development in the Medical Information space.”

Save the dates will go out in the next couple of months, as well as survey requests for content. Please keep on the lookout and participate if you can. We look forward to seeing everyone in 2016!

Welcome to the IRMS Family!

Online Business Applications was happy to welcome 9 new clients to the IRMS family throughout 2015, all which chose to subscribe to OBA’s Hosted/Cloud service. Our new friends made up a wide spectrum including; small bio-tech and pharma companies, mid-size global bio-tech and pharma companies, as well as two CRO’s. These new users (some not so new), have been enjoying our flagship offering IRMS, whether the Classic system or the new web-based IRMS 6.

Additionally, five have purchased and have deployed our new IRMS-Mobile to not only their field based teammates, but also for MI team members who attend conferences and congresses. This tool allows users to submitted open or closed MI request directly into IRMS. We are privilege and honored that these 9 companies have instilled their trust in OBA and IRMS and we look to continue to build and foster our “Raving Fans” throughout the industry.

Below is a snapshot of our “New Arrivals”!



Intercept-

Intercept and OBA met at the 2014 DIA Annual Conference in San Diego, CA and had come to terms on using the IRMS Classic System in late 2014. After an initial configuration, Intercept decided to include the IRMS-PC and AE Capture Modules, but also, be one of the first clients to implement IRMS 6. They are currently in the process of validating the system and have future plans to expand IRMS to affiliates.

Intarcia Therapeutics-

Intarcia contracted with OBA in preparation for drug approval. A long time IRMS Admin and User as well as cheerleader for IRMS had taken over the MI operations and immediately new he wanted IRMS for his database. The first order of business was to implement not only IRMS, but IRMS Mobile for the use of its “Badge Scanning” technology at upcoming conferences. Today, further projects are forthcoming and it looks to be a bright future between OBA and Intarcia.

BioMarin-

After years of discussions on and off, OBA and BioMarin finally were able to work together to implement IRMS. The project was going to be global in nature, with affiliates in all corners of the Earth. After careful and strategic planning on both side, the plan was set and implementation commenced. Working closely together for ~5 months, IRMS was deployed successfully to 5 Divisions, encompassing EMEA, US, Canada, Latin America and Asia Pacific.

Purdue Canada-

Purdue Canada had been a prospect for nearly 3 years before finally getting the ok to purchase IRMS. As Purdue US had been a client for many years’ prior, the continuity and familiarity between the two companies worked to be a valuable asset. We are extremely happy to have Purdue Canada as a part of the OBA community.

Alexion Pharma-

Alexion Pharma had been a client of OBA dating back to 2006. When the system was not needed anymore, it was decommissioned. In 2014, new management took over and wouldn’t you know, they were Raving Fans of IRMS! After some discussion on how to implement the system for the US and their EU affiliates, the IRMS project began. Alexion is looking at a Go-Live date of early 2016!

Sarepta Therapeutics-

Sarepta Pharma implemented IRMS during Q3 and Q4 and we are continuing to work together closely on further projects. Sarepta is utilizing IRMS, IRMS-AE, IRMS-PC and IRMS Mobile for managing their request within the US. We are very pleased with the work and effort both teams of put forth in order to achieve very tight timelines.

PTC Therapeutics-

PTC Therapeutics will be launching IRMS for their Medical Information use in the EU initially, then in the US upon drug approval. This project is currently in progress with a projected Go-Live date of Q2. OBA is familiar with the key users at PTC, as they have been clients and prospects in their previous positions. We at OBA are extremely excited about the future between our two companies.

Ipsen Pharma-

The relationship between OBA and Ipsen dates back to 2013, when we met with the Australian team at the ARCS Conference in Sydney. Over the next two years, there were times where we were close, but budget was not approved. In early 2015, Ipsen initiated a world-wide search for a Global Medical Information solution. After a long RFP process, OBA and Ipsen came to terms on an agreement for rolling out IRMS 6 system to all affiliates within Ipsen. Currently, the first phase is expected to Go-Live in Q1 2016, with subsequent phases being launched over the next 18 months. The teamwork that has been dedicated to this endeavor has been topnotch and we are looking forward to a long-term partnership!

Quintiles-

OBA is delighted to welcome one of the largest CRO’s in the world into the IRMS family! The Medical Information team at Quintiles and OBA have had a very strong relationship over the years, but the timing for partnering with each other was never quite right. Not until mid-2015, when OBA and Quintiles began discussing the opportunities that IRMS could lend to Quintiles business. Once again, after much discussion and hard work, from both sides, OBA and Quintile were able to come to terms on an agreement for IRMS to be the standard Medical Information solution at Quintiles. Currently, the implementation project is going full steam ahead and looks to be completed towards the end of Q1 2016.

As you can see, 2015 was a very busy and productive year for OBA and we see 2016 being just the same. If you have any question on IRMS or IRMS related products, please feel free to reach out to IRMS Sales at Sales@irmsonline.com