The Disconnect (4/7)

You now understand the full landscape they've navigated before that RFP reaches you. Unfortunately, many CRO PMs aren’t aware of the scale. This creates a profound disconnect that damages partnerships, limits career growth, and costs both sides valuable opportunities.

While the Sponsor is viewing it through a strategic lens (investment protection, stakeholder management, competitive positioning, career risk, …), the CRO PM is viewing the situation through an operational lens (efficiency, best practice, resource utilization, … ). 

Several reasons:

1. Different Career Paths: Many CRO PMs have only worked on the CRO side. They've never experienced the Sponsor perspective and interpret Sponsor behavior through the only lens they have: operational execution. Often the same for those on the Sponsor side.

2. Information Asymmetry: Sponsors rarely share their full strategic context with CRO partners. RFPs don't include sections on "competitive threats" or "partnership strategy" or "board pressures." 

3. Organisational Silos: At CROs, BD often has relationships and strategic context that doesn't get fully transferred to the operational PM team. The strategic insights that could bridge the gap get lost in the handoff.

4. Time Pressure: Both sides are operating under intense time pressure and  rarely have the time for thoughtful conversations that would build mutual understanding. 

5. Lack of Framework: Most CRO PMs simply don't have a framework for understanding the Sponsor's journey. Without that framework, they can't ask the right questions or interpret the signals they're seeing.

This disconnect in perspective creates predictable misunderstandings throughout the project lifecycle. Let’s review five common scenarios.

Scenario 1: Budget Pushback

During proposal negotiations, the Sponsor pushes back on several budget line items. They question why site monitoring visits (MVs) cost that much, what’s the need for so many project management hours…. The Sponsor needs the CRO to help them get maximum value for their investment.

What the CRO tends to think is that they're being cheap, don't understand what it actually costs to run a quality clinical trial and are going to be a difficult client throughout the project. Maybe we should walk away.

Budget consciousness is the only financial stewardship of limited resources that must fund a multi-year journey. The PM should try understanding the Sponsor’s constraints and priorities in order to find efficiencies and propose a plan to deliver successfully without compromising quality or timelines. For example, ask “What's most important to you? Speed to results, risk mitigation, or cost efficiency?" This reframes the conversation from negotiation to problem-solving.

Scenario 2: Timeline Urgency

The Sponsor wants the FPI in 2 months. However, no site list has been offered. They push for faster site activation, expedited ethics submissions, and compressed timelines throughout. 

For the CRO PM the timelines are unrealistic. Clearer expectations about what's actually achievable are needed. 

However, the Sponsor is worried after their competitor’s announcement of their FPI in their Phase I already. Every month of delay gives them a market advantage. Their board was promised to have Phase I data in 15 months to support partnership discussions that are already underway. If the timeline is  missed, the entire strategic plan and funding of Phase II could be seriously affected."

Timeline urgency isn't unreasonable pressure. It's competitive necessity and strategic commitments made to stakeholders. However, the Sponsor needs to understand the external limitations of the CRO (e.g. regulatory approval timelines, the need of translations….). This is the strategic PM’s job: explain the drivers for the timeline extension and propose alternative scenarios, with their costs, specific risks to compressing further. Discuss the alternatives based on their key priorities. This acknowledges their urgency while educating them on trade-offs.

Scenario 3: Protocol Amendment Resistance

Three months into the study, the CRO PM identifies an opportunity to improve efficiency. Perhaps reducing the number of PK timepoints or adjusting visit windows. It seems like a minor change that would help sites and reduce costs but the Sponsor resists. They need to discuss it internally including their Regulatory and think about implications.

The PM doesn’t understand why it seems they are making this so complicated and worries about the enrolment. 

However, the Sponsor is worried to change the protocol agreed to with the  FDA during pre-IND discussions. Those PK timepoints are specifically designed to validate predictions from our preclinical PK models. If they don't collect them their dosing strategy for Phase II might be jeopardised. 

The protocol is usually the result of months of strategic alignment, regulatory planning, and stakeholder communication.

As a CRO PM, ask about the rationale behind a specific protocol element that you consider as a potential unnecessary add on. Afterwards, if still convinced the change would be positive, they word it as an optimization opportunity should it fits in their regulatory and strategic perspective. This respects the Sponsor's strategic planning while still identifying improvements.

Scenario 4: Data Review Intensity

The Sponsor wants to review every piece of data immediately as it's available. They schedule frequent data review meetings. They ask detailed questions about every adverse event, even those that are clearly unrelated to study drug. They want explanations for every protocol deviation.

This sounds totally unreasonable and out of scope to the CRO PM. 

However, the Sponsor’s  saw a concerning liver enzyme elevation in their 6-month dog toxicology study that resolved but left them worried. 

Data intensity isn't micromanagement. It's risk management informed by preclinical concerns and accountability to stakeholders.

To improve the working relationship, the exposure should have shown with the safety signals they are most concerned about based on their clinical work. With this in mind the budget should have been finalised including the reporting required (immediate attention vs. routine monitoring).

Scenario 5: Communication Frequency

The Sponsor wants weekly project status calls, in addition to regular reporting. They email between calls with questions. They want to be included on correspondence with sites. They ask for frequent forecasts and projections.

What the CRO PM thinks is that they are spending more time reporting than executing. If they trusted the CRO, the project could run faster while maintaining the bi-weekly calls and email updates. “They're consuming our time with status requests instead of letting us manage the project."

Communication frequency isn't micromanagement or lack of trust in the CRO. It's a Sponsor managing upward to stakeholders demanding visibility.

Designing a customised dashboard with all the information needed by the Sponsor fed in as much real time as possible would respect their needs while making communication more efficient.

The Opportunity

Understanding the sponsor's strategic context at a very early stage will save the CRO PM a lot of headaches and will improve the project relationship. The sooner the CRO PM becomes the strategic partner the Sponsor actually needs, the higher chances of success for all parties.

Topics to fully understand and offer in the RFP include the following examples:

1. Proactive Protection of Their Investment: Instead of saying "Here's the budget breakdown", offer "Here's where we can optimize costs without compromising quality, based on our understanding of your constraints"

2. Strategic Risk Management: instead of  saying "This is a normal AE that happens in oncology studies", offer "Given your competitive timeline and partnership discussions, here's how we're monitoring for the signals that matter most to your stakeholders"

3. Contextual Communication: Instead of saying "We're 3 weeks behind on site activation", offer "We're 3 weeks behind on site activation, which affects the first patient in (FPI) by 2 weeks. Here's our recovery plan and zero impact in the overall timelines"

4. Partnership in Problem-Solving: Instead of saying "The protocol as written is difficult for sites", offer "I understand this protocol design reflects regulatory strategy, however, this is the site challenges we're seeing. Let's think through how to address it while protecting your regulatory position"

5. Translation Between Worlds: Instead of saying "Sites need more flexibility", offer "Help me understand the regulatory and strategic constraints so I can work within them while optimizing site experience"

The CRO PMs who understand this distinction, and provide what Sponsors actually need, become indispensable. They win more bids, get more follow-on work, and build careers as trusted partners rather than interchangeable vendors. Not because they are more operationally skilled than their peers, but because they're more strategically aware. They've made the effort to understand the landscape their Sponsors navigate and this transforms how they show up as partners.

My suggestion to you for you next:

1. Proposal development: ask about competitive landscape, partnership strategy, and stakeholder pressures.

2. Kick-off Meeting (KOM) prep: explicitly ask: "Help us understand what success looks like from your strategic perspective, not just the operational deliverables."

3. Project execution: Communicate in terms of impact to strategic objectives, not just operational status.

4. Project challenges: Position problems and solutions in terms of protecting the Sponsor's investment and strategic positioning.

5. Data reviews: Connect operational events to strategic implications: "This enrolment rate puts us on track for data readout in Q3, which aligns with your partnership timeline."

In the next post, we'll see some brain-based strategies that work with your neurobiology, not against it.