Without the proper plans in place, it’s easy to miss key information along the way leading to sub-optimal implementation and lagging user adoption.  In order to avoid these pitfalls, it is critical that organizations prepare sufficiently for this change, both from a people and technology perspective. Having a solid plan is extremely important to ensuring a successful implementation. As Benjamin Franklin once said, if you fail to plan, you plan to fail.

In this blog, we will discuss 2 key steps that will ensure a successful result. Although seemingly intuitive, there are nuances that will ensure critical activities are not overlooked. These two critical steps should not be missed on your journey.

Define Your Vision

Guiding Principles & Vision

The first step is defining the company’s vision. This is done by bringing the group together and working with the leaders in the organization to develop a vision statement, along with guiding principles. The objective is to collate a succinct set of goals that the organization can retain as the selection and implementation criteria standards for the future state. For example, the organization might want to speed up submission times as a goal so that the quality can be improved or both. Another area might be authoring more efficiently. There may be other aspirations that each organization has to get on a journey towards an end solution.

“As is” State of the Business

While developing the goals, there should also be a baseline of where the organization is today. Many organizations may have the desire to jump ahead and dive into the new, shiny, exciting possibilities of the future state and systems that can help get you there, however, having a solid sense of where you are now before embarking on the best path to improvement is critical.

We’ve seen many organizations get tripped up because they don’t know what they don’t know, and with global processes, various tool, spreadsheets, SharePoint emails, any other aspects, it’s very easy to miss a critical piece of the puzzle, if you don’t step back and develop a solid plan.

It starts with defining the scope of the work and following up with business processes. The organization should also review the system landscape, issues, gaps, and areas of opportunity. This helps in bringing to light the areas that are not clearly apparent.

“To be” State of the Business

After the “as is” state has been developed, the organization can learn from that, the vision, and guiding principles to bring those together and define what the future state or “to be” state will look like.

Then depending on how you’re going to go about implementation there may be the need of a different level of detail in your future state. Astrix’s recommendation is to start by mapping out what you’re looking to do from a high-level process flow. From there, the organization can dive in deeper as needed. This can be an iterative process. As you learn more about your organization’s needs and the vendor capabilities, and as you get closer to the solution selection, you can iterate back on that future state and add detail as you learn more.

Identify Capabilities

Another piece of the puzzle is identifying and prioritizing the capabilities – understanding what is needed to maintain continuity (what you have today) and to bridge the gaps (what is needed in the future). Ask yourself, will these capabilities enable the organization to reach the desired future state? Does the organization have the right technologies, for example analytics recording, or workflow orchestration, in place already?

Identify and documenting these needs will allow the organization to better assess the vendors as you move forward into a solution selection and ultimately drive your implementation later on.

Once you know the capabilities you need to implement, if you haven’t already, make sure to take the time to fully assess technology options and evaluate based on the organization’s specific requirements. Organizations typically view even foundational capabilities in very different ways, so, look at these technologies based on what your organization needs and how they will fit into your specific situation.

Summary

It is critically important, when building out a strategy and plan relative to any new business and/or technology endeavor, to have the right internal staff and external organizations involved to assist in the process. Formulating the appropriate approach along with the proper processes and technology is imperative.

Astrix’s team of professionals in our Strategic Consulting Service Practice have worked with many of the top life science organizations and leaders to assist them with respect to their business needs in these areas. As a technology-agnostic partner, without a preconceived preference for a specific supplier or product, we work closely with your team to ensure solutions are reviewed and incorporated into your business so that you succeed in realizing your vision and achieving your organizational goals.

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.

The post Implementing a RIM System and 2 Critical Steps to Success (Part 1) appeared first on Astrix.

Major research institutions and academic centers operate in an increasingly complex global network of scientific collaborators. In recent years, there has been a rising number of partnerships between non-profit research institutes and pharma, driven by cuts to academic research budgets, waning pipelines, and the pharma industry’s emphasis on open innovation.  This can make regulatory compliance that much more difficult.

Despite the rise in number of collaborations, there are a number of challenges pharma and academia face when establishing their alliances, in particular aligning on opposing goals. For pharma, these partnerships are about gaining access targets, molecules, and academic investigators that can help get cures to the clinic. Academia is driven by the “publish or perish” culture – which can also cause some IP concerns for pharma. Similarly, rather than focusing solely on the clinic as the end goal for a molecule, academia’s efforts are often directed toward determining how and why a drug did or didn’t work. These often-cited challenges, though significant, do not tell the whole story.

Research regulatory compliance is emerging as a major factor in public-private collaborations. To win major partnerships and sustain operations in an increasingly competitive research funding environment, research compliance must be on your list of organizational priorities. No longer an insular activity, research in a complex partner ecosystem with increasingly complex regulations requires serious on-going attention, whether from an outside party or internal compliance function or both. From data management to animal use and the requirements surrounding human subjects, assessing your compliance risk even in exploratory research environments is no longer a nice-to-have. Unfortunately, many traditional academic centers face a lack of institutional infrastructure and resource to deal with compliance.

The research administration environment grows increasingly complex with changing regulations, inconsistencies among agencies, lack of information (meaningful and timely reports), thus generating more risk than institutions recognize. There remains a vast disconnect between the award environment, (during which the funding agency and the PI focus primarily on the research itself) the degree of flexibility that is perceived to exist while the research is being conducted, and the audit environment that follows. The current environment often places increased emphasis on accountability during a time when many institutions are faced with significant financial pressures and mandates to reduce staff. Numerous research institutions have indicated that compliance costs have grown during the past decade. More telling than the increases in associated research compliance costs are trends showing that these costs have increased more rapidly than the associated direct research expenditures, such as salaries, lab supplies, and research equipment.

Research compliance impacts:

• Academic Medical Centers
• Cancer Centers
• Healthcare Systems with Research divisions
• Research Institutes
• Universities

In addition to increasingly complex regulations, the trend towards moving on-premise systems to cloud-based or hybrid environments adds further complications to the research compliance landscape. While the move to the cloud contributes to organizational agility and efficiencies, cloud-based environments must be validated appropriately and are often managed differently from traditional on-premise solutions.

What are the Areas of Compliance Emphasis?

So, how do research institutions get a handle on the issues? To start, let’s identify the current areas of compliance that should be addressed. This widespread, yet non-exhaustive, list of regulatory compliance issues creates a complex charge for the research compliance program at an institution.

How do I Design a Comprehensive Compliance Program?

Before designing a program to address research compliance in your organization, you must first have a deep understanding of your processes, data management practices, infrastructure and IT systems that are impacted. The first step and best practice is always to start with a thorough analysis of the current state, including in-scope business processes, systems, and procedures (such as current data management practices) to ensure quality compliance with governing regulations. This can be performed by an internal audit or oversight function or pursued with an external third-party with the appropriate experience in system and process auditing, regulatory and compliance, risk management processes, laboratory informatics systems, and organizational quality management practices.

Issues to Consider: Assessing Your Compliance Environment

• History and culture of the institution, barriers to change, mission and vision
• Commitment of institution’s leadership to invest in improvement and “champion” change initiatives
• Effective mechanisms for internal controls across organizational units
• Optimization of information flow within and between compliance, administration and operating units
• Staffing levels, roles, responsibilities & delegated authorities
• Revamping policies & procedures
• Training & education for compliance
• Current service level agreement requirements and maintaining an appropriate level of compliance

Once you have performed the analysis, turn your attention to developing a comprehensive compliance program designed to get you to where you want to be over time. The following eight elements are considered as necessary for a comprehensive compliance program.

8 Elements of a Comprehensive Compliance Program

• Compliance Leadership
• Policies and Procedures
• Training
• Communication
• Monitoring
• Enforcement
• Corrective Response
• Roles and Responsibilities

Implementing the plan is time consuming and requires buy in across the organization, dedicated resources with defined roles, and enforcement mechanisms. In general, a proactive approach to creating a compliance program will allow an institution to manage its compliance risk without imposing unnecessary constraints on the institution’s operations. Strong compliance programs not only benefit research institutions by reducing the risk of significant non-compliance but also tend to increase accountability, clarity, and information flow across the enterprise.

ABOUT US:

Astrix has been an industry leader for over 25 years in helping scientific organizations implement and integrate improved informatics systems in the laboratory. Our experienced team of expert informatics consultants bring together technical, strategic, regulatory and content knowledge to provide the most effective solutions to problems faced by scientific organizations. Our domain experts have helped hundreds of companies globally effectively navigate their digital transformation journey.

The post Academic Institutions and Regulatory Compliance in the Labs: Why It Matters appeared first on Astrix.