Business technology, in any industry, is only as good as the people, planning, and processes around it. After ten years of e-clinical implementations, we can say from experience that operational planning requires a very industry-specific lens.

The heavily regulated nature of the clinical research industry presents an opportunity for operational leaders: adapting the organizational planning playbook. In other industries, increased oversight is generally received as a threat to operations remaining nimble and responsive. In Life Sciences industries, where safety of patients in need of new medicines should be the top priority, we recognize that innovation necessitates heightened accountability and the highest expectations for standards and quality. As an industry, we adapt to this in an interesting way. Organization leaders respond to the expedience and efficiency challenges of regulations by re-examining and rewriting best practices that benefit the industry as a whole.

Traditional leadership instincts and planning methodologies designed for less regulated industries can fail or fall extremely short in the execution of clinical research, particularly as it applies to things like eTMF management. As a result, it is important to establish some broad guidelines to serve as a compass for planning and forecasting in an environment with such strict parameters. The following five considerations can help organizations make better decisions:

• 1. Know Your Framework

  Who are your internal subject-matter experts? Those that best understand the industry expectations and constraints must serve as the foundation for setting the parameters within which you will operate. The regulations by which we must abide are absolute, and they imply rules that must be established as part of any plan. Owning these from the start is essential. Leverage your internal experts or consult external experts to understand the framework that will govern execution. Plans cannot consider the regulatory considerations retroactively. Put first things first!

  For example, European companies who onboarded to various clinical solutions in 2017 without performing their due diligence are now subject to fines and patches to adhere to the new GDPR standards. Tapping an internal or external expert to compare the policy to the organization's goals and new systems of record could have avoided this entirely. The rules in our industry are complex, but there's always someone who knows them well enough to save you from fines and it won't cost nearly as much as the possible fine to hire them, if they are not already on your team.

• 2. Know the Expectations

  What are the long-term and short-term company goals? Most effective teams track and measure what they do, but regulated teams have no choice. Your goals need to be realistic, actionable, and trackable. Being regulated means being subject to audits/inspections. It is essential that teams establish the metrics, timelines, documentation, audit trails, etc. that will not only allow you to measure success, but will allow you to prove you’re succeeding in compliance in the eyes of regulatory agencies. Much like the first point, you need to understand what needs to be tracked and measured before you’re designing your playbook. This also reinforces the first point. If you don’t know your parameters, you will end up missing essential information from your tracking and measurement. This can lead to inflating costs due to inefficiency, or worse, fines.

  A perfect example for this is the transition from paper Trial Master Files (TMF) to electronic Trial Master Files (eTMF). This change was a natural and logical evolution in the monitoring, collating, and control of clinical trial documentation, and yet the methodologies for tracking and applying these new technologies required expanding company skills, from specific TMF management skills, to expanded TMF and technology skills. When Trial Interactive entered the eTMF space over 10 years ago, they had the opportunity, as market innovators, to influence and drive product design, application, and innovation, and long-term, strategic plans were conceived and implemented to achieve success within this new and exciting paradigm.

• 3. Know Your Team

  What can your organization count on you to deliver? Strictly regulated industries require ever-expanding requirements, more training, and a deeper knowledge base. It can be a challenge getting enough qualified resources to fill your needs. Take a resource-based approach to your planning and hold your framework and expectations up to your talent roster to understand your strengths and weaknesses, including who can help you establish the first two steps above. Again, you need to be clear on whether you have the available expertise to help meet the goals that you articulated by establishing your tracking and measurement. You must also be aware of your team’s abilities, allocations, and priorities, and be ready to set client or stakeholder expectations.

  This important process requires broad, end-to-end vision across many different groups. For example, documents have to be collected (CRAs), processed (Clinical Operations team), and filed (document specialists) within a certain time period for each stage, and if you don’t have the right team members in the right roles, processes can degrade quickly.

• 4. Know Your Risks

  How will you reach your goals and stay compliant at the same time? If you’ve followed the first three steps, you have a pretty good view of your parameters, how to track your operations, and how well your team is designed to execute and where the gaps might be in your internal expertise. You’ll now need to control for risk. Your analysis for tracking against the framework will have identified a good amount of the information you need to monitor to control risks. Don’t stop there. Look at who will be overseeing the work and how they will be overseeing it. Do you have the right systems and processes in place to support the regulatory framework, tracking, and necessary compliance? Your biggest risks reside in processes that do not fully account for executing and overseeing compliant work. Are your teams clear on the risks and the processes that will control them? Many teams try to simply use technology to solve this problem, but it always boils down to people and processes. Identify the workflows required to meet your goal and align your standard operating procedures accordingly. Then, provide training both before and during the execution of your plan to keep your teams knowledgeable of their role in controlling risks.

  For example, if a client milestone has a firm date by which it must be completed, and your team is at risk of missing that deadline, risking your relationship, reputation, and most importantly the client’s success, you may want to perform a risk analysis to determine the cost and benefits of corrective action. This may include committing more resources, taking the work to a specializing firm, or bringing in consultants to expedite the deliverable timeline. This example applies not only to risk, but also to benefit, as the relationship between the two is directly inverse. By mitigating risk, you also increase the potential for benefit. Can you impress a client by going the extra mile to ensure success? Could that lead to a reputation in the industry of a reliable and dependable partner? Which brings us to the last point…

• 5. Know Your Benefits

  On the other side of risks are benefits. You’ll want to understand benefits just as well as you understand your risks because positive outcomes and gains in operational excellence translate to strategic advantages. When risks are controlled and benefits are understood, you have yourself a recipe for continuous improvement. Knowing what you stand to gain from your operational strategy will guarantee you refine your tracking and measurement and also keep teams aligned by keeping the end in mind. In the course of execution, you will always discover unknown risks and benefits, but you can minimize surprises by accounting for as many as you can possibly know or imagine. Remember that every action contains within it the potential for both exposure and advantage. Stack the odds in your favor through planning and preparation!

  A solid strategy for eTMF management, for example, can be repeatable and establish your team as thought leaders as you create standards and practices that can be adopted by other teams.

Often the goals and plans of the organization, and any specific team within it, may feel constrained by strict compliance rules; however, in regulated industries, the playbook necessitates that we accept and harmonize our approach to operational planning. The scrutiny our teams endure creates an opportunity to adapt and execute with a keener eye for quality and overall effectiveness. Putting the right elements of the planning process first allows leaders to rewrite the rules of operational planning to be high performers in a compliance-focused context.

Want help with your TMF/eTMF best practices? Contact us anytime at info@trialinteractive.com or visit us at trialinteracive.com to learn more about our e-clinical innovation.