No Surprises: PharPoint’s Transparent Approach to Changes in Scope

As study needs evolve and new information emerges over the span of a multi-year clinical trial, sponsors must sometimes navigate changes in scope (CISs) with their clinical trial vendors.

While certain changes to study plans impact study budgets (such as protocol amendments) and are understandable, disingenuous hidden costs and surprise budget overruns are never welcome.

If a CIS is required, PharPoint believes it should never come as a surprise.

On the occasion out of scope work is necessary, PharPoint’s approach prioritizes proactive transparency and ensures sponsors understand why a change is being proposed, what it means for their study, and we obtain our sponsor’s written approval prior to completing the work.

Why Changes in Scope Happen

Despite best efforts to define study assumptions and sponsor requirements upfront, clinical trials are sometimes long, complicated, and over the course of years, needs often evolve.

Common drivers of CISs include:

• Protocol amendments;
• Changes due to slower or faster than anticipated enrollment;
• Funding changes resulting in the need to pause or shift study approach;
• The expansion of a study (e.g., the addition of an extra study arm); and
• Evolving client needs (e.g., later requests for a bespoke reporting tool).

When Scope Changes Signal Deeper Issues

Sometimes, CIS requests stem not from evolving study needs, but from issues that could, and should, have been avoided altogether.

Poorly defined assumptions, vague proposals, or unrealistic study budget estimates can lead to misalignment before your study even begins. One particularly egregious, but not unheard of, example comes in the form of a bait-and-switch. Early in the proposal process, a CRO may offer low-cost bids to win contracts by making unrealistic or poorly informed assumptions about trial needs.

Once a contract is signed and the study is underway, it becomes clear that additional resources are necessary. This results in a chain of CISs and a rapid increase in study cost, often bringing total spend up to more closely align with other bids received. These cost increases may force sponsors into a difficult position: accept higher costs or scramble to renegotiate terms (or find a new partner altogether) mid-study.

In other cases, sponsors may feel like they’re being nickel-and-dimed or left in the dark after receiving a bill for increased costs without clear explanation or perhaps without a formal CIS at all. These scenarios show a lack of transparency and can erode trust, making it harder to build a true partnership.

PharPoint’s Transparent CIS Process

PharPoint is dedicated to being transparent stewards of our client’s studies – and that means proactively forecasting potential changes to a study budget and communicating these changes to the client for review and approval.

Our approach is designed with our clients’ needs in mind. This includes:

• Proactive planning to reduce changes
• Early communication and clear signoffs
• Efficient execution to keep studies moving forward

Proactive planning to reduce unnecessary changes

PharPoint’s cross-functional subject matter experts are heavily involved during our budget builds, ensuring our team provides realistic assumptions that limit changes down the line.

During our early conversations with sponsors, we are happy to work with teams to better plan for contingencies and clearly understand how changes in a study may impact overall costs. For instance, if your trial has potential risks (e.g., if you may require additional analyses), PharPoint can work with you to ballpark estimated costs before they are formally added to the project scope.

It is important to note that for instances where a proposal has been requested prior to the creation of a comprehensive study protocol, details included within a proposal are subject to change as your strategy evolves in the early planning period. To mitigate this risk, you may consider reaching out to a consultative CRO like PharPoint to clarify your trial details. By collaborating with a consultant, sponsors can confidently articulate their needs and ensure that their requests for proposal (RFP) contain the necessary details to allow for accurate bids.

Early communication and clear sign-offs

Once a project has begun, PharPoint’s project leaders ensure sponsors are informed of potential scope changes as early as possible. This includes a clear sign-off process before beginning any work that may incur additional costs to ensure clients understand and approve of changes.

Efficient execution to keep studies moving

If it is agreed that a change in scope is necessary, the bureaucracy behind getting a change in place shouldn’t unnecessarily hinder your study’s progress.

PharPoint’s Proposals group aims to efficiently and strategically develop CIS documents that provide additional clarity for sponsors, complementing conversations that have already occurred between a client and their study lead. PharPoint works diligently to limit ambiguity, ensuring our team can maintain agile study support for clients both transparently and without delay.

PharPoint’s CIS process includes input from cross-functional operational teams, with a focus on providing information that is both easily digestible and comprehensive.

This may include information such as:

• An executive summary of changes
• Detailed changes in assumptions and/or costs
•  Any anticipated adjustments toward billing

If a sponsor has questions regarding these changes, our team is accessible via phone or video conference and happy to discuss the document to ensure alignment.

Partner with PharPoint for a Smarter Approach to Scope Management

When you’re working with a CRO that’s truly client-focused, you should have the experience of a flexible, adaptive team that wants to provide the right services to meet your needs and overall budget – not make your experience more difficult. PharPoint’s transparent approach ensures that changes, when necessary, are managed efficiently with full visibility and minimal disruption.

For more information about PharPoint’s transparent approach to working with clients, reach out to our team.