Can a Global Regulatory Index (GRI) Transform Communications with Regulatory Affiliates?

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences. Follow @Mcktweet

Streamlining the regulatory submission process is essential to getting products to market faster today. And yet, for most Life Sciences organizations, this process is time consuming, inefficient and complex – even more so when partnering with Regulatory Affiliates worldwide. Globe-3While sponsors are ultimately responsible for the safety of the products available in global markets, they struggle to gain visibility into regulatory activities. On the flipside, Affiliates struggle to get access to critical submission documentation in a timely manner and to create an efficient process while using a whole host of local tools (spreadsheets, network drives, email, paper, etc.) to manage their work. The result is a disjointed process that lacks efficiency, traceability and streamlined communication.

Next week, the Drug Information Association (DIA) is hosting their Regulatory Submissions, Information and Document Management Forum in Bethesda, MD. On Tuesday, EMC’s own Mary Gallagher, well-known in the industry, will be speaking on “Managing Global Submissions – From Identifying Core Content to what is Actually Submitted.” I had a chance to speak with Mary about her presentation and why she thinks it’s an important topic to highlight. Mary Gallagher

Question: Mary, when you say “Core Content” or “Global Regulatory Index” what do you mean?

Answer: I am working with several clients on the concept of a Global Regulatory Index (GRI). (Some clients also refer to this as a Core Dossier or Corporate Package.) The objective is to create a package of all sponsor approved submission content for a given product at any point in time. This content would be created and approved by the Sponsor and could be used anywhere in the world for submissions. Local Operating Companies (LOCs) / Regulatory Affiliates could then create local health authority submissions based on the approved GRI.

Question: What is driving the need for something like this in the industry?

Answer: The underlying driver is the desire to reduce risk and improve efficiency. Sponsors are ultimately responsible for all heath authority submissions and yet there is a real lack of visibility of what Affiliates are submitting as well as concerns about accuracy. In Gens & Associates’ 2015 RIM and affiliate benchmark study, it found that 40% of affiliate time is spent coordinating and managing regulatory information, with approximately 25% of that time spent on non-value-added activities, such as data re-entry.

In our interactions with clients, there seems to be a lack of confidence in the quality of product registration information maintained in global systems. Companies are looking for ways to ensure accurate information and a single source of the truth yet ensuring that Affiliates have the information and easy access they need to unify both the process and ensure timely, bi-directional communication.

Question: What would be required to utilize a GRI?

Answer: First, a process would need to be defined that takes the needs of both the Sponsor and the Affiliates into account. The goal should be to define a process that works for both parties and reduces non-value add activities and rework. Obviously, it also needs to be flexible and adaptable to manage global regulatory requirements while helping to ensure compliance. Another thing that is necessary is that the business process needs to be intuitive requiring minimal training and limited oversight of affiliates who have limited time and resources.

Question: How would the GRI be structured?

Answer: Ideally, we would recommend creating it by using a Virtual Document (VDoc) in Documentum. For those unfamiliar with the term, a virtual document is basically a document composed of other documents. It’s a way to organize (and “granularize”) complex documents or submissions, which are authored by multiple authors, sometimes in different functional areas. Check out this short video. Virtual Documents also boost efficiency by enabling certain functions to be performed on a large number of documents in a single action (such as sending a task to a user to have them work on a virtual document instead of having to send and track multiple documents individually.)

Question: Who would “own” the GRI and how would it be kept current?

Answer: There are numerous people and systems involved in creating a regulatory submission. From a process perspective, the Product Portfolio Management team would be involved as they determine where new products will be marketed and create the overall product marketing strategy. From an ownership perspective, the Submission (GRI) Manager would define the content and timeline of the GRI releases. This person would also communicate with the content authors, LOCs/Affiliates and ensure that everyone has the tools they need to meet the required timelines. When there is a change to the GRI, Affiliates / LOCs can be notified via email with a link to the GRI (and a read receipt for compliance tracking purposes) or via a task in their Regulatory Submission planning tool.

Question: When talking about access, what kinds of security concerns need to be addressed?

Answer: Ideally, the GRI would be posted in a secure location such as a Sponsor’s content management system. LOCs / Affiliates would have access directly to the GRI. However, due to the availability of very granular security, access permissions can be set so that Affiliates only have access to approved content and only content relevant for the products sold in their market. In addition, Affiliates would only have permission to read and copy the content – they could not edit and revision the content. This provides the Affiliate with easy access to relevant content but ensures Sponsor control over the content itself.

Question: This all sounds like a much more efficient way to work. What additional advice would you give Sponsors and Affiliates?

Answer: There are multiple questions that need to be answered when defining a GRI and the associated processes. In addition there are numerous tools and systems involved in the Regulatory Submission process and they can help facilitate information sharing and increase efficiency. I encourage any company struggling with this process to talk with their content management vendor and also their registration management and publishing vendors. By working together, companies can develop a process that enables end-to-end visibility, ensures a comprehensive single source of truth for both Sponsors and Affiliates, facilitates communication and (hopefully) speeds time to market.

  • How does your organization handle this process today?
  • Do you experience any of the challenges discussed?

Let us know about your experience and goals!  And, if you or a colleague will be attending DIA’s Regulatory Submissions, Information and Document Management Forum next week, be sure to catch Mary’s full presentation on Tuesday, February 9th from 10:30 – 12:00pm in the ERS Track!

Ringing in the New Year with Digital Transformation

Jill Orbell

Jill Orbell

Marketing Program Manager in the Enterprise Content Division at EMC. Twitter: @jillorbell

Is it February already? January flew by! I wanted to share a quick recap of our blogs from the past month. We rang in the New Year by celebrating EMC being named a leader in the Magic Quadrant for Customer Communications Management Software for the third year in a row. We also shared how it’s possible to have your cake and eat it too as the Enterprise Content Division continues to hold our leadership status in the recent Ovum Decision Matrix: Selecting an Enterprise Content Management Solution, 2015–16 report, and it’s follow-up the Ovum, Enterprise Content Management: The Suite Perspective.Digital Transformation-2

But what about the future? Rohit Ghai noted in his blog, “The Best Way to Predict the Future, is to Create it”, the importance of helping customers thrive in the future. So, to piggy back on his focus on the future, throughout the month of January we thought it would be fitting to share insights on digital transformation and its impact on the future of business.

Jennifer Edwards highlighted this impact sharing how digital transformation is more than technology. As businesses become more digital, they have an opportunity to become more human. Technology helps us enable better customer experience. Jennifer notes, digital transformation “allows companies to create more engaging experiences for a new breed of consumers who have grown up with cell phones in their pockets and laptops at their kitchen table.” What is your organization doing to transform to meet the demands of today? Are you ready for Continue reading

Miami Dade Achieves CJIS Compliance for Evidence Management

Rob Silverberg

Rob Silverberg

Director and CTO, Enterprise Application Architecture, State and Local Government and Education. Follow @RobSilverberg1

One of the many challenges that state, city, and county IT departments face is how to manage public safety digital evidence. This is the data from the police and sheriff, video surveillance, 911 recordings, and includes crime scene pictures and videos as well as police reports and other crime and investigation information. The FBI has established guidelines for how this digital evidence must be protected and managed and documented these policies in the Criminal Justice Information Services (CJIS) Security Policy for evidence management. This set of standards can be perceived as daunting for a city or county IT department when confronted with the question from their police IT leadership.  “Is the Crime Scenecounty content repository CJIS compliant?”

I was pleased to discover that one county IT department has taken the lead in establishing a CJIS compliant evidence repository for their public safety data. Miami Dade County has achieved CJIS compliance for their new Enterprise Content Management (ECM) system which was purchased several years ago to replace their legacy ECM environment. The legacy system used for content and evidence management at the county was older and outdated. The new ECM environment has been implemented and the County’s IT staff was challenged by the department of public safety to make this new environment CJIS compliant.

The County’s Enterprise Applications ECM team reviewed the CJIS documentation and attended CJIS compliance training. They learned about the key requirements for evidence data protection which includes encryption for data in flight and data at rest.  CJIS compliance also Miamiextends to the policies and procedures used by the IT staff for systems containing digital evidence. They learned that simple things like data center access must be strictly controlled in order to achieve compliance. Systems administrators must not be able to see digital evidence even with administrator access to the system, as well as other data security requirements defined by the CJIS policy.

The County chose to use Secure Sockets Layer (SSL) to protect data in flight over the network and an encrypted Storage Area Network (SAN) for data at rest. They also used an ECM repository with powerful access controls and security model, and specific components for additional encryption and data security. They reviewed and revised data center access policies and procedures and now have a CJIS compliant ECM repository, ready to protect and manage the most crucial digital evidence gathered by the department of public safety.

Miami Dade is leading the way in using advanced technologies for the benefit and safety of the public. They have achieved CJIS compliance success where others have only started and have become an example for others to follow.

How do you manage digital evidence in a CJIS compliant system?

New Approaches to Cancer Care at the Nexus of Integrated and Personalized Care

Simona Vellani

Simona Vellani

Sr. Marketing Manager, EMEA. Follow @VellaniSimona

We’re excited to have Silvia Piai, IDC Health Insights Analyst, join us today as our guest blogger, sharing insights on cancer care to highlight healthcare transformation.



Silvia Piai, IDC Health Insights Analyst

In the last few years, as an analyst at IDC Health Insights I have focused most of my research on integrated care delivery models and their impact in overcoming challenges related to access, quality and sustainability of care systems. More recently, I’ve become fascinated by the opportunities offered by personalized medicine: tailoring prevention, treatments and disease management to individual biological characteristics of patients, recognizing and valuing their diversity to provide care in a more targeted and effective way. What really fascinates me in researching these two approaches is that in terms of benefits delivered, the combination is greater than the sum of its parts. Together, they can deliver paradigm-shifting scenarios, making health systems truly patient centric, higher quality of care and more financially viable.

The combination of integrated and personalized care relies upon an increasing interdependency of processes and blurring of boundaries between healthcare stakeholders. In this converged scenario, healthcare stakeholders are required to act on the whole spectrum of biological, clinical and social determinants of health, and therefore they depend on a 360-degree view of the patient.

Cancer care is an area where the adoption of integrated and personalized care — enabling collaboration and evidence-based decisions through the support of appropriate information management — yields huge potential.

Accounting for 20% of deaths, cancer is the second highest mortality and morbidity cause in Europe, after cardiovascular diseases. Advances in clinical research have disclosed a significant number of causes, potentially allowing the prevention of at least one third of all cancers. Also, early detection and targeted therapies, could increase the chances to cure some of the most common types. To translate this potential into reality, cancer care needs to improve the quality and efficiency of diagnosis and treatments, as well as the Continue reading