Finding your people: effective HR strategy for early-stage biotech 

HR is more than just an administrative function; it’s a critical strategic tool, especially for early stage biotech companies.  

But why is HR strategy so important for early-stage biotechs in particular? And how can you craft a HR strategy that fosters scientific discovery, helps you scale, and keeps you competitive?  

HR challenges in early-stage biotech: 

 Early-stage biotechs face a unique set of obstacles. Perhaps the most pertinent are:  

  • Scarcity of specialized talent. A limited pool of candidates for highly technical scientific roles means securing talent is hard and can quickly drain precious capital.  
  • The need to balance operational efficiency with scientific risk-taking. Biotech companies must create a culture that fosters intelligent risk-taking and creativity while also ensuring that business operations remain efficient and focused. Creating a culture that encourages experimentation while maintaining a practical, results-driven environment, though, is tough.  

To address these challenges and set the foundation for long-term success, biotech companies can’t simply rely on traditional hiring practices. They need a well-crafted HR strategy that is tailored to these obstacles and adapts to evolving needs.  

So, what does that look like? 

Attracting scarce, specialized talent with limited resources: 

With biotech companies often unable to offer the competitive salaries needed to secure the best and brightest talent, they must rely on more creative approaches, such as:  

  • Offering equity compensation. Offering ownership stakes can help attract talent with the promise of long-term success despite cash restraints.  
  • Using flexible hiring models. Companies that are priced out of full-time roles should consider part-time experts and consultants to gain specialized expertise without committing to large, fixed costs.  
  • Leveraging founders’ networks. Identifying specific talent through existing connections, rather than working with recruiters, can cut costs on the search for new candidates, too.   

By using these strategies cash-strapped biotech companies have the best chance of building winning teams while preserving their capital.  

Encouraging scientific risk-taking while protecting operational efficiency: 

 As noted above, success in biotech demands a supportive space for productive risk-taking and failure, while still keeping operations efficient.  

 Key practices include: 

  • Creating a culture that celebrates scientific rigor while accepting failure as an unavoidable part of drug development. 
  • Hiring people who understand both the scientific and the business realities of biotech. 
  • Facilitating and maintaining open communication between scientific and operational teams. 
  • Developing a hiring strategy that evolves with the company to maintain the right balance of operational oversight and scientific innovation  

“Creating an environment where the team can safely experiment and learn from failures is key. We used to hold funerals for projects. It was cathartic and showed our teams that we want them to take risks. If you are going to fail, fail fast and learn from it—let it inform your science.” —Gregg Beloff, Co-Founder and Managing Director, Danforth Advisors, a Danforth Health company. 

Building a fit-for-purpose HR strategy for today and beyond: 

Building a strong HR foundation is key to navigating the complexities you’ll face as an early-stage biotech company, from attracting top talent to fostering a culture that balances risk-taking with commercial viability.   

But securing a winning team amid talent shortages and building an innovation-friendly culture are just two of myriad HR challenges an early-stage biotech will face.   

 What’s more, as biotech companies scale, those challenges morph and evolve into a different beast altogether, demanding more comprehensive and nuanced HR support.   

Find out more about those challenges and how best to navigate them, by connecting with our HR experts. Reach out to our team today.  

Danforth Health Launches to Empower Life Science Innovation

Integrated platform helps life science companies move from discovery to commercialization with greater efficiency and impact

WALTHAM, Mass. – September 10, 2025 – Danforth Global, Inc. today announced the launch of Danforth Health, a unified platform built to empower life science innovation. By delivering integrated, cross-functional expertise at every stage – from discovery through commercialization – the platform reduces risk, streamlines execution, and maximizes the potential of scientific breakthroughs to reach patients with efficiency and impact.

Danforth Health unites its affiliated entities under a shared identity and purpose, coordinating services across finance and human resources, regulatory and clinical, investor and public relations, commercial and marketing, market research and analytics, and market access and value. This connected model gives companies one adaptable partner to help them advance through critical milestones – whether entering the clinic, preparing for IPO, or executing on commercial strategy.

Chris Connors, CEO of Danforth Advisors, will serve as CEO of Danforth Health, guiding strategy across all affiliated entities.

“Advancing new therapies from discovery to market requires not only the achievement of critical development and regulatory milestones, but also a strong business foundation, effective storytelling, and early attention to commercial strategy,” said Connors. “Danforth Health was built to provide that full balance – combining strategic guidance and hands-on execution across disciplines so companies can focus on what matters most: the innovation.”

Danforth Health was built both organically and through strategic acquisitions, beginning with the founding of Danforth Advisors in 2011 and fueled by investment from Avesi Partners. Today it also comprises the expertise and services of Advyzom, Argot Partners, Benchworks, Elite BioPharma Consulting, PharmaDirections, and VPMR —trusted partners to companies across the life science ecosystem.

About Danforth Health
Danforth Health is a unified platform purpose-built to empower life science innovation. By integrating the capabilities of best-in-class affiliates, Danforth Health provides tailored, cross-functional support across finance and human resources, regulatory and clinical, investor and public relations, commercial and marketing, market research and analytics, and market access and value. The model is built for flexibility, scalability, and impact — serving life science companies at any stage and helping them move faster, smarter, and more efficiently to achieve transformative outcomes for patients. Headquartered in Waltham, Massachusetts, Danforth Health has partnered with more than 1,800 life science companies around the world. Additional information is available at www.danforthhealth.com.

Clinical Trial Financial Management: A Practical Guide for Biopharma Professionals 

Insights From an Expert: Written by Rene Stephens, Managing Director, Danforth Advisors, a Danforth Health Company

Why Clinical Trial Financial Management Matters 

Running a clinical trial isn’t just about patient visits and data collection; it’s also about making sure the financial management side runs smoothly. When finances get messy, it can slow down the science, frustrate leadership, and create stress for the teams doing the work. This guide is built for you: those on the front lines making sure Clinical Operations, Finance, and Procurement stay in sync. We’ll break down how a strong clinical trial financial management process can make your job easier, keep budgets on track, and avoid last-minute surprises. 

Caught Between an Invoice and a Hard Place 

In clinical trials, timelines change, patient enrollment slows down (or speeds up), and site invoices don’t always show up when you expect them. The problem? Finance needs accurate numbers now, Clinical Ops needs the flexibility to adjust plans, and vendors have their own schedules. Without a financial management system that ties all this together, things slip through the cracks, and that’s when costs creep up. 

The Three Big Things to Get Right in Clinical Trial Financial Management 

  1. Accurate & Timely Tracking: You can’t fix what you can’t see. Track real activity (patients, site activations, visits) and tie it directly to spend. 
  1. Proactive Risk Spotting: Look for signs that costs might run over: delayed site openings, slower enrollment, or CRO scope creep. 
  1. Clear Communication: Make sure Clinical Ops, Finance, and Procurement are speaking the same language and sharing the same data. 

How to Put Clinical Trial Financial Management into Action 

Here’s the good news: you don’t need to reinvent the wheel. Danforth’s methodology and fit-for-purpose tools give you a monthly rhythm that keeps everyone aligned: 

  • Gather real study activity data from Clinical Ops (EDC reports, site status, enrollment projections). 
  • Pull vendor and CRO cost updates. 
  • Compare what’s been done to what’s been billed. 
  • Update forecasts so Finance sees the real picture, not just invoices. 
  • Review as a team so everyone’s on the same page before numbers go to leadership. 

Avoid These Common Headaches 

  1. Relying only on supplier reports: Vendors don’t always have the same view of your budget priorities. 
  1. Late or missing site invoices: This can throw off accruals and make Finance chase numbers. 
  1. Forecasts disconnected from reality: If your forecast is based on the original plan, but enrollment has shifted, it’s already outdated. 

What This Looks Like in Practice 

  • Saving $350K in CRO Advances: A sponsor was about to hand over a huge upfront payment to a CRO. We helped cut that in half and spread the payments over time, freeing up cash for other priorities. 
  • Fixing Forecast Accuracy: We spotted a patient timeline issue in a CRO report, updated the forecast, and avoided a major budget miss. 
  • Cleaning Up Investigator Payments: By tracking from the EDC instead of CRO pass-through estimates, we improved accrual accuracy and avoided month-end surprises. 

Practical Tips for Better Financial Oversight 

  1. Have a single shared file or dashboard that Finance, Clinical Ops, and Procurement can all use. 
  1. Keep a monthly checklist so nothing gets missed, especially vendor updates and site activity data. 
  1. Flag big changes early; leadership likes solutions, not surprises. 
  1. Document decisions: when the audit comes, you’ll be glad you did. 

The Bottom Line 

You’re the bridge between the science and the numbers. Strong clinical trial financial management keeps trials on budget, provides leadership with the insights they need, and makes your role less stressful. It’s about building habits, using the right tools, and keeping the conversation going across teams.   

Need help improving your clinical trial financial processes? Danforth Health specializes in financial planning, forecasting, and vendor oversight for biopharma companies. Contact us today to get started. 

The Three Essentials of Effective Biotech Change Management Communication 

In any biotech change management project, one element consistently determines whether the process succeeds or stalls: how you communicate with your people. 

Many leaders put significant energy into designing the change itself: the strategy, the timelines, and the operational details. But when it comes to telling the story of that change, they falter. 

Sometimes it’s because they assume everyone is already on board. For example, during periods of biotech growth, leadership may think the company’s upward trajectory speaks for itself. They may believe morale is high enough to carry the change forward without a structured communications plan. 

 It’s an innocent assumption… and it can be an expensive one. 

The Danger of the Information Void 

If employees aren’t given a clear, transparent view of what’s happening during a time of change, they will fill in the blanks themselves. And in times of uncertainty, those stories are often negative. 

An impactful change management communication plan answers three core questions for employees: 

1. The What 

Spell out the change with precision. Avoid vague statements like “We’re restructuring” or “We’re improving workflows.” These broad phrases leave too much room for speculation. Specificity creates clarity, and clarity prevents harmful narratives from taking hold. 

2. The Why 

The rationale behind a change is as important as the change itself. Why this change? Why now? Why in this particular way? People are more motivated when they understand the reasoning and can connect it to a tangible benefit for the organization, their team, or themselves. 

3. The How and Impact 

Explain the steps that will bring the change to life and outline the effects on both the business and each individual. When people know what to expect, uncertainty fades and trust grows.  

Honoring the Individual 

Effective change management communication goes beyond processes and timelines. It’s also about acknowledging the human side of change. 

When you explain the impact at the individual level: “Here’s how this will affect your role, your day-to-day work, and your opportunities going forward” you show that you’ve thought about them, you understand their contribution, and you value it. 

As our experts say, “Be granular when explaining the impact of the change to individuals. This shows that the company has thought about the person, knows what they do and values their contribution. This is about honoring the individual.”  

Is your organization facing the complexities of change management?  

Danforth Health has supported numerous life science companies through the intricacies and sensitivities of change management. Contact our team today. 

The Biotech Founder’s Guide to Targeting and Engaging Investors 

Raising capital in biotech is an ongoing, demanding process. With today’s funding landscape favoring later-stage companies and a select few standout startups, early and mid-stage biopharma firms face increasing challenges attracting investor attention. 

While market factors like interest rates and sector trends are beyond your control, the relationships you build with investors are where you can truly make a difference. Success often hinges on how well you identify, engage, and nurture the right investors for your company’s unique stage and goals. 

Why Investor Targeting is More Art Than Science 

Creating a “target list” of investors isn’t just about naming the biggest or most famous venture capital firms. A strategic, bottom-up approach is critical. Your list should reflect your company’s development phase, fundraising goals, and fit with investors’ current interests and capacity. 

 Consider these factors when building your list: 

  • Existing relationships and meeting history: Who do you already know? Have prior conversations laid groundwork? 
  • Ownership and investment data: Which investors have stakes in similar companies or therapeutic areas? 
  • Investor readiness: Who has available capital (“dry powder”) and appetite for new investments? 
  • Current focus areas: Which investors are actively funding your specific biotech sub-sector? 

This targeted approach ensures your outreach is efficient and resonates with those most likely to invest. 

Crafting a Thoughtful Outreach Plan 

Once your target list is assembled, success depends on how you engage. Consider these best practices: 

  • Leverage warm introductions: Personal connections increase meeting acceptance rates and build trust early. 
  • Time outreach strategically: Align communications around relevant news flow, such as data readouts, partnership announcements, or industry conferences. 
  • Prepare tailored messaging: Customize your pitch to reflect the investor’s known interests and priorities. 

Managing Relationships Over Time 

Capital raising is a marathon, not a sprint. Effective relationship management includes: 

  • Tracking all interactions: Keep detailed records of meetings, follow-ups, and investor feedback. 
  • Establishing a feedback loop: Actively seek and incorporate investor insights to sharpen your pitch and materials. 
  • Reassessing and prioritizing: Regularly revisit your target list to tier investors by interest and likelihood of investment. This focus helps you allocate your time where it counts most. 

Why Nurturing Relationships Matters 

Strong investor relationships go beyond a single funding round. They build trust, enable honest dialogue, and often unlock valuable strategic support beyond capital, such as introductions, industry expertise, and operational guidance. 

Well-nurtured relationships increase the chances that investors will stick with you through the ups and downs of biotech development, helping you secure future rounds and scale your business effectively. 

Ready to accelerate your capital raise with expert strategic guidance?  

From CFO leadership and financial planning to investor targeting and outreach, Danforth Health is here to help you secure the funding your biotech company deserves. Connect with our experts today. 

Start Here: 5 Key Steps to Build a Biotech Compensation Strategy

In supporting 1,500+ biotech companies, we’ve seen it all.  

And we understand that in the early stages, it’s common to approach a biotech compensation strategy informally. Leaders are often quick to rely on peer anecdotes, venture capitalist guidance, or one-off negotiations. 

However, we’ve also seen that as biotech startups grow, this lack of compensation strategy structure soon becomes a problem, leading to overspending, internal misalignment, and worst of all, losing top talent. 

A thoughtful biotech compensation strategy from Day 1 sets your team up for success, bringing clarity and fairness to your pay practices while aligning with your mission, culture, and financial realities.  

Building a Biotech Compensation Strategy Step 1: Define Your Compensation Philosophy 

Your compensation philosophy is your north star, a formal document that outlines your company’s stance on: 

  • Base pay 
  • Bonuses 
  • Cash vs. equity mix 
  • Promotions and raises 
  • Non-monetary perks 
  • Remote or flexible work policy 

For example, your philosophy may define that your company targets the 50th percentile for both cash and equity compensation within your industry. It should reflect your values and financial strategy, as well as any legal requirements, and typically requires input from your CEO, CPO, and CFO, with final approval from the board. 

Building a Biotech Compensation Strategy Step 2: Create a Compensation Matrix 

A compensation matrix operationalizes your philosophy. It includes:

  • Job descriptions & postings
  • Job families, levels, and career ladders
  • Benchmark salary data
  • Clear pay bands
  • Promotion pathways

This framework moves you away from ad hoc decision-making and toward standardized, scalable compensation practices. 

 Pro Tip: Use reputable benchmarking data to establish realistic, competitive salary bands. 

Building a Biotech Compensation Strategy Step 3: Plan Your Team and Address Outliers 

Once your matrix is in place, analyze where your current employees fall within it. Compare salaries against experience, skills, title, and performance. You may uncover: 

  • Overpaid outliers with little rationale 
  • Underpaid high performers who risk attrition 

 Address these gaps with a gradual, transparent adjustment plan. 

Building a Biotech Compensation Strategy Step 4: Tailor Your Benefits 

Compensation isn’t just about salary. Non-monetary benefits play a big role in employee satisfaction. Start by reviewing: 

  • Demographics: Are employees early-career PhDs with student debt? Consider a qualified loan forgiveness program or a formal professional development budget. 
  • Industry trends: In 2025, mental health support is increasingly expected. 
  • Direct feedback: Surveys and focus groups can reveal what truly matters to your team. 

Building a Biotech Compensation Strategy Step 5: Communicate with Clarity 

Even the best compensation strategy fails if it isn’t clearly communicated. Ensure every employee understands: 

  • Your compensation philosophy
  • How salaries and raises are determined
  • What they can do to grow their earnings

Use simple language, multiple channels, and involve managers and leadership in training. Transparency builds trust and reduces confusion or dissatisfaction. 

Set the Foundation Now for Long-Term Success 

Creating a compensation strategy for your biotech company might feel daunting, but it pays off in retention, performance, and compliance with evolving pay transparency laws. 

A strong compensation philosophy, combined with a practical matrix and clear communication, gives your biotech company the structure it needs to grow with confidence and attract the talent that will power your mission. 

Need help developing your compensation strategy? 

Danforth Health offers strategic HR guidance for biotech companies throughout all stages of their journey. Reach out to our expert team today. 

Clinical Trial Financial Accruals: What Every Clinical Professional Needs to Know

Clinical trial financial accruals often seem like a mystery to those outside of finance. But understanding how these accruals work is critical for clinical professionals who manage study operations and budgets. Whether you’re communicating with finance teams or overseeing vendor activities, learning the fundamentals of clinical trial financial accruals will help you run more efficient, compliant trials. 

What are Financial Accruals? 

In simple terms, financial accruals refer to the accounting practice of recognizing expenses when they are incurred, not when the cash is actually paid out. In a clinical trial context, this means tracking the services and activities that have occurred in a given month (e.g., patient visits, lab tests, CRO activity) and estimating their cost, even if the vendor hasn’t sent an invoice yet. 

These estimates are critical for proper monthly and quarterly financial reporting, especially in organizations that follow Generally Accepted Accounting Principles (GAAP). For example, if an investigator site completes five patient visits in April, the cost of those visits must be accrued in April, even if the invoice comes in May. 

Why Accruals Matter in Clinical Trials 

Accurate Financial Reporting: Investors, executives, and auditors expect financial statements to reflect the company’s current liabilities. Underestimating or overestimating trial costs can result in misleading reports, which can affect business decisions and even stock performance. 

Improved Budget Management: Trial costs are often spread out over months or even years. Accruals allow sponsors to track spending against the budget more precisely, flagging overages or cost-saving opportunities early on. 

Regulatory and Audit Readiness: Accurate and well-documented accruals help ensure transparency and readiness for internal audits or regulatory inspections. They also show that the organization maintains a disciplined approach to financial management. 

Common Challenges in Accrual Estimation 

Fragmented Data: Costs are often spread across multiple vendors, CROs, labs, imaging services, and investigator sites, making it difficult to get a full picture without robust tracking systems. 

Communication Gaps: Clinical teams may not always understand the level of detail finance teams need, leading to late or inaccurate reporting. Likewise, finance professionals may lack insight into clinical timelines and workflows. 

Inconsistent Methodologies: Some companies estimate based on invoices, while others use actual service logs or site forecasts. Without standardization, results can vary significantly from month to month.  

Best Practices for Clinical Teams 

Build Cross-Functional CommunicationSet up recurring check-ins between clinical operations and finance during study start-up and ongoing execution. This helps both sides align on expectations, timelines, and deliverables. 

Maintain Clean and Consistent Data: Ensure that all vendor contracts clearly define cost-per-activity and invoicing terms. Use centralized systems to track patient activity and vendor performance in real time. 

Invest in Training and Tools: Educate clinical project managers on the basics of accruals. Equip them with templates or software that help simplify the tracking and forecasting process. 

Need expert support to manage your accruals? 

When clinical teams understand how clinical trial financial accruals work, they become better partners to finance teams, reduce budget errors, and strengthen the operational backbone of research. Having supported 1,500+ organizations, Danforth Health specializes in financial operations for life science companies. From accrual tracking to vendor forecasting, our experts can help you streamline your process and improve accuracy. Contact us today. 

How Small Biopharma Teams Can Punch Above Their Weight in Clinical Operations 

Some of the most exciting life science breakthroughs are not coming from industry giants, but from small, scrappy biopharma companies operating with limited headcount, lean budgets, and sky-high expectations. These emerging players are proving that success in clinical development doesn’t require scale; it requires focus, strategy, and the right partnerships. 

But how do you execute high-stakes clinical trials with a lean team? 

The answer lies not in doing more, but in doing what matters most, exceptionally well. 

Lean Doesn’t Mean Weak 

There’s a persistent misconception in biotech that lean teams are at a disadvantage. But in reality, a streamlined approach often creates more agility, speed, and cohesion. The key is resisting the urge to overbuild, whether that’s staffing, systems, or SOPs, and instead building intentionally for the stage you’re at. 

For small biopharma companies, every dollar and decision must serve a purpose. Clinical operations should be a strategic extension of that mindset: designed to de-risk, drive value, and hit milestones without unnecessary layers or complexity. 

Strategy First, Not Systems First 

Having partnered with 1,500+ life science companies, we know that it’s tempting to start building infrastructure right away: filling roles, buying software, writing policies. But those steps are only useful when they’re anchored in a clear clinical strategy. 

Small teams benefit most from fit-for-purpose trial design: protocols shaped to hit regulatory goals, unlock new funding, or generate decision-making data. That often means working with experienced regulatory consultants early, prioritizing adaptive trial designs, and focusing narrowly on endpoints that matter. 

The result? You reduce the risk of costly rework, gain investor confidence, and build real momentum. 

Owning the Plan, Outsourcing the Execution 

With limited internal bandwidth, outsourcing is a given. But that doesn’t mean handing off control. Lean clinical teams should remain the strategic hub of every trial, while CROs, functional service providers, and consultants handle execution. 

What separates successful companies from the rest isn’t just who they outsource to, but how they manage those relationships. 

Smart vendor oversight is about structure, not scale: clear roles, shared KPIs, and consistent check-ins. One skilled clinical lead, armed with the right governance model, can keep multiple vendors aligned and accountable. 

Quality Without Bureaucracy 

Compliance is non-negotiable. But building a regulatory and quality function from scratch can feel overwhelming for a small company. The good news: it doesn’t have to be. 

Start with the essentials, documentation that supports Good Clinical Practice, and build outward. Lean companies often benefit from fractional QA consultants and cloud-based tools that provide structure without bureaucracy. It’s not about having a 100-page SOP library; it’s about having the right 10 pages in place. 

Partners Who Extend, Not Drain, Your Team 

One of the most overlooked drivers of operational success? Picking partners who behave like an extension of your team

Not every CRO or vendor is built for the scrappy, fast-moving world of early-stage biopharma. Bigger isn’t always better. The right partner will align with your culture, communicate transparently, and bring flexible staffing models that scale with you. They’ll move fast, solve problems, and stay focused on your goals, not just their deliverables. 

A great partner doesn’t just lighten the load; they elevate your execution. 

Small Teams, Big Advantage 

At the end of the day, your size can be your superpower. 

Lean biopharma companies are often more responsive, easier to work with, and more focused than their larger counterparts. Clinical sites and vendors appreciate sponsors who are accessible and decisive. Patients benefit from faster trial activation and more personalized recruitment strategies. 

When you stay lean and build intentionally, with the right strategy, tools, and people, you can run clinical operations that rival companies twice your size. It’s not about doing everything. It’s about doing the right things really well. 

Want to learn more about lean clinical operations?

Contact us to learn how our teammates at Elite BioPharma Consulting, a Danforth Health company, support small companies in scaling smartly and executing with excellence. 

Case Study: Clinical Finance Advisory

Background

A private, clinical stage gene therapy company engaged Danforth Health’s Clinical Business Operations team to examine and resolve challenges related to the expenses of five clinical studies being managed by one Clinical Research Organization (CRO).

Danforth Health’s Role

Applying specialized expertise in clinical contracting, including clinical study accruals and related forecasting, the team identified multiple areas to avoid both over-payments and under-accruals. Findings included the following:

  • Out-of-scope activities were being performed and were omitted from monthly accrual and forecasting reports. The Danforth team requested accrual data for all activities, including bookkept change notices, avoiding under-accrual of $900,000.
  • Inflation cost of $2 million across trials was not included in the Statement of Work, budgets or month-end accrual reports. The Danforth team investigated the impact of inflation on study budgets to avoid under-accrual of $400,000.
  • No detail was being provided for investigator grants. The Danforth team performed an audit of investigator grant payments, ultimately uncovering $200,000 in potential over-payments. Specifically, the audit revealed the following:
    • Lack of internal controls for duplicate visits (same subject and date); estimated overpayment of $52,000.
    • Internal control/process to update (reverse/pay) not functioning; estimated overpayment of $3700.
    • Payments made to sites for invoices lacking proper detail or supporting information (for example, a $57,000 hospital stay).
    • Payments made to sites for invoices that appear to be for same service/same time period or duplicate items on same invoice; estimated overpayment of $25,000.
    • Invoices pending approval and periodic site fees excluded from accrual file, resulting in under-accrual.
    • Numerous visits in Electronic Data Capture (EDC) had not been paid due to insufficient data and lack of CRO follow-up to ensure complete and accurate data entry from the sites.
    • Internal controls and processes not working as described, including visits deleted from EDC after payment without a credit being issued to site for “deleted” visits; estimated over-payment of $4700.
    • Payments to sites for visits and site costs in two different file layouts, lacking fields to cross-check and flag duplicates; estimated overpayment of $3700.

Based on these returns, the client has implemented Danforth’s custom-designed clinical finance tool as a long-term remedy to better predict clinical study spend and forecasting going forward.

Results

Implementing improved practices has led to a better understanding of the client’s clinical study liabilities/accruals and payments with more predictable forecasting. This methodology can also lead to improved relationships with CROs and sites by identifying trends and mitigating conflicts. 

Seeking help with clinical finance management?

Schedule a conversation with one of our experts.

CRO Contract Best Practices: Why life science companies should treat CRO contracting as a strategic asset, not just a legal formality. 

For early-stage life science companies, selecting the right Contract Research Organization (CRO) is one of the most critical decisions in clinical development. At Danforth Health, having supported over 1,500 life science companies, we’ve found that what’s often overlooked is not who you choose, but how you structure the CRO contract. This foundational step can make or break the success of your clinical partnership. Implementing CRO contract best practices can help safeguard your investment, enforce accountability, and improve study outcomes. 

CRO Contract Best Practices Tip #1: Build Expectations Into the RFP 

One of the most overlooked CRO contract best practices is integrating key terms and expectations into the Request for Proposal (RFP), not just the final contract. By requiring CROs to respond to your proposed terms in the RFP stage, you filter out vendors unwilling or unable to meet your standards, giving you leverage before negotiations begin. 

CRO Contract Best Practices Tip #2: Document the Selection Process for FDA Readiness 

If your study comes under FDA review, you’ll need to justify your CRO selection. A best practice is to document your selection criteria, questions posed during the RFP process, and the responses received. This supports audit-readiness and demonstrates a thorough vetting process. 

CRO Contract Best Practices Tip #3: Tie Payments to Performance with Milestone-Based Models 

A key CRO contract best practice is to move away from time-based billing in favor of milestone-based payments. This aligns incentives with outcomes and helps ensure that deliverables, not delays, determine compensation. You can even include “earn-back” clauses to reward high-performing CROs with full contract value if they exceed expectations. 

CRO Contract Best Practices Tip #4: Include Consequences for Missed KPIs 

Defining Key Performance Indicators (KPIs) in your contract is only half the battle. A top CRO contracting best practice is to tie those KPIs to consequences, refunds, penalty clauses, or renegotiation triggers, so that performance has real weight. This sets clear expectations and helps both sides stay accountable. 

CRO Contract Best Practices Tip #5: Protect Yourself with Sponsor-Only Termination Rights 

Your contract should include termination for convenience, but that right should rest solely with the sponsor. Allowing the CRO to unilaterally terminate could jeopardize your clinical program. Fair terms for non-payment termination are reasonable, but they should include buffers, such as requiring two consecutive late payments before termination is permitted. 

CRO Contract Best Practices Tip #6: Define and Control Change Order Authorization 

One final best practice: don’t let change requests become liabilities. Specify who within your organization is authorized to approve change orders, and make clear that only approved, signed change orders, not informal requests, can result in billing. This avoids scope creep and financial surprises. 

A well-structured CRO contract isn’t just a safety net; it’s a strategic framework for clinical success. Embedding CRO contract best practices throughout the selection and negotiation process helps ensure alignment, reduce risk, and maximize outcomes. 

At Danforth Health, we support life science companies in building smart, performance-driven contracts that protect their investment and accelerate clinical execution. Need help designing your CRO strategy? Contact our team today.