As the clock ticks down to the deadline for standardized Identification of Medicinal Products (IDMP) submissions in the EU, pharmaceutical companies are scrambling to get their data in order. They face multiple challenges, including an increased demand for internal resources and funding, and an uncertain regulatory environment. (Post-Brexit, even the EMA’s future address is unknown, as it inevitably will leave its current London headquarters.)

LEVERAGE IDMP COMPLIANCE TO IMPROVE YOUR DATA AND ADD VALUE TO YOUR BUSINESS

ARTICLE

By Sue Metz Principal Consultant, PAREXEL Consulting

On top of that, deadlines and data goalposts are shifting. The first EMA IDMP submissions deadline was 2016; now it’s targeted for late 2018. EMA data elements are still only in draft form and could change. Controlled vocabulary services are still not ready.

Internally, companies are grappling with the difficulties of standardizing data from disparate disciplines and business units (regulatory and manufacturing), as well as across far-flung geographies.

However, rather than viewing this as a burden, companies would be best served by seeing this as an opportunity to develop a comprehensive data strategy that will add value to their businesses

DERIVING ROI FROM YOUR COMPLIANCE INVESTMENT

Companies have no choice but to comply with IDMP in Europe; doing so is an investment that must be made. Although the EMA is the first agency to implement IDMP, the FDA and the rest of the world are close behind. The FDA has worked with the International Organization of Standardization (ISO) to generate standards for products, services, processes, materials, and systems, signaling its intent to implement them shortly.

The resources in time and money required to transform processes to comply with these new data elements, formats, and terminologies will be considerable.

All companies – small, medium, and large – need to minimize the operational risks and maximize the potential benefits of this investment. Even start-ups that aim to be acquired need to consider how their own data systems will merge with a prospective buyer’s as compliant data will command a premium, while non-compliant data may incur a penalty.

Facing looming deadlines, tight timelines, and resource constraints, some companies may be tempted to take a piecemeal or too narrow approach to IDMP compliance. That would be a mistake.

Data and its governance are critical for the pharmaceutical industry as it generates vast amounts of interconnected data (probably more than any other). Optimizing one part of a system without addressing others will create system static that will sabotage both operational performance and compliance efforts.

That said, IDMP compliance should not be addressed through a “big bang” approach. The many historic failures of big bang technology implementations have led to an understanding and acceptance of the wisdom of taking an iterative, stepwise approach to process improvement and change.

Such an approach requires that companies only move forward with a comprehensive strategic plan. A narrow focus (such as treating IDMP compliance solely as an IT issue) can never be comprehensive. In addition, a plan

YOUR JOURNEY. OUR MISSION.® | 3

Most data are not dirty, but multiform. This is because data systems typically are custom designed with fields, formats, and values intended for a specific purpose. But before data can pass from one system to another, they must be transformed.

In order to be interpretable by different systems, data must be tagged, stored, and made accessible by standardly applied terms, definitions, categories, and protocols. For example, missing records and/or unpopulated fields need to be identified and handled in a consistent manner by all the systems in your organization.

Once you have assessed the state of your data with a pilot study, you must develop both short-term and long-term plans to revise suboptimal processes and harmonize (conform) the data so that it can be mined.

The relevant term of art for data governance is establishing a “master data philosophy. Master data is defined as “any non-transactional data that is considered to play a key role in the core operation of a business and is re-used for multiple purposes” (EMA, 2016).

When data is harmonized, it can provide insights. For example, instead of asking five different department heads to consult their spreadsheets to answer a question, a CEO could query one set of company-wide data.

MAP OUT A PLAN THAT CAN BE EXECUTED IN STEPWISE, TACTICAL INCREMENTS

IDMP compliance will be a big job. At the same time, overinvesting in elaborate systems, or training, while requirements are still evolving is not prudent.

Right now, the EMA is still determining basics such as which data fields will be required, and what drop-down menus will look like in the first iteration of the IDMP implementation. For example, the first release of the Referentials Management System (RMS), part of EMA’s SPOR (Substance, Product, Organisations and Referentials) project, was delivered on June 15, 2016. At this point, there is clarity on just four controlled vocabularies (route of administration, dosage form, container type, and units of measurement), with many more still to be determined.

Consequently, the best plan is one that allows for gated implementation: Focus on the EMA’s requirements since those come first, but always keep the FDA and other global agencies in your line of sight.

allows companies to remain agile in a fluid compliance environment: Elements of a plan may need to be delayed, or fast-forwarded, as events unfold.

Fortunately, the recently extended deadlines for implementation of the first EMA iteration give companies time to adopt this more strategic approach. Companies can use the extra time to broaden their strategic vision and elaborate a coordinated, holistic strategy focused on adding value to the business through better data governance.

In PAREXEL’s worldwide practice, we’ve found that a sound IDMP compliance strategy confers business advantage as it results in high quality, harmonized data that can be queried efficiently. Here’s how your company can start its journey.

ASSESS YOUR DATA HONESTLY

A comprehensive data governance strategy starts with a thorough and frank assessment of the current state of your data. Often, it takes both internal and external experts to produce such an assessment. Why both? Internal stakeholders understand where data reside, and how they currently work, while external SMEs bring to the table knowledge of possible future requirements and state-of-the-art solutions and tools.

A pilot study, scrutinizing, say, a representative set of marketing authorization submissions, is an excellent way to put your data through its paces. A well-run pilot can take several weeks.

A pilot study should answer the following questions:

• Is the data in the right format?

• Is it where you expected it to be?

• Is it complete?

• Does each data element have an owner responsible for its quality?

• How is unstructured data handled?

When it comes to preparing for IDMP compliance, companies cannot afford to be satisfied with cursory answers to these questions. Quality is the foundation of a robust strategic compliance plan.

HARMONIZE YOUR DATA, DON’T “CLEAN” IT

A common way of speaking about data is that it is dirty and needs to be cleaned, or scrubbed. But this is the wrong way to think about.

YOUR JOURNEY. OUR MISSION.® | 4

Implementing a master data philosophy – which will entail a company-wide commitment – can be best accomplished when its goal is to make a company more competitive, not just compliant.

A hub and spoke data governance system that can be queried efficiently and used to interact with regulatory authorities across the globe is the pearl within the IDMP compliance oyster.

Companies that use IDMP compliance to add value to their business by enhancing and enriching their data management processes will find themselves not just compliant, but more competitive.

A holistic strategy, combined with incremental tactics, will enable companies to get the most out of their IDMP compliance investment.

OPPORTUNITY KNOCKS

High quality data is a huge asset for a pharmaceutical company. Although many companies understandably may be reluctant to invest money and time on IDMP compliance, where the ROI is seemingly less compelling and immediate than it is in other business activities, companies have to do it, so it is their responsibility to unleash the potential energy of compliance and optimize its benefits.

WHEREVER YOUR JOURNEY TAKES YOU, WE’RE CLOSE BY.

CORPORATE HEADQUARTERS

195 West Street Waltham, MA 02451 USA +1 781 487 9900

Offices across Europe, Asia and the Americas

www.PAREXEL.com

© 2016 PAREXEL International Corporation. All rights reserved.