Evaluating a Business Process Outsourcing (BPO) Relationship in Pharma: From Pre-Commercial to Post Launch

For emerging pharmaceutical companies, the journey from pre-commercial to post-launch is filled with high-stakes operational choices. One of the most consequential is whether and how to outsource essential business processes. The right BPO (Business Process Outsourcing) partner(s) can reduce operational strain, accelerate timelines, and help ensure compliance in a demanding regulatory landscape.

When considering and evaluating a BPO, there are some key questions that should guide your thinking.

1. What business functions are needed to support my near-term and longer-term product(s), and which are likely to be the most complicated or critical to success?

2. Which BPO vendor(s) has/have strength in the specific areas that best suit our company and product profile?

3. What functions and data should remain in-house?

4. Should we identify a single BPO vendor, or do the specific needs of my product warrant consideration of a best-of-breed approach by operational area?

Industry experts Rob Ririe and Kevin Ward explore these questions and the who, what, why, when, and how of BPO evaluation with a focus on the unique challenges of emerging pharma operations.

The Pre-Commercial BPO Relationship

The earliest conversations about outsourcing should happen 18–24 months before a potential launch. At this stage, determining what to retain in-house and what to delegate is especially pivotal.

Emerging pharmaceutical companies often operate with lean teams, meaning BPO oversight can land across multiple functions — operations, finance, and market access — with frequent role overlap. In some cases, no single owner is accountable for certain business functions, so alignment of a BPO relationship owner can be challenging.

“Sometimes the finance lead is doubling as the contracts manager,” notes Ward. “So accountability often falls wherever someone has the bandwidth and not necessarily the expertise.”

The solution? A proactive cross-functional oversight group, even a small one, to monitor service delivery, compliance, and performance.

Why BPO Strategy Matters for Operational Success

BPO planning should always start with the brand’s channel strategy, as channel strategy and operational design are tightly linked. Whether distributing through retail, specialty pharmacy, direct-to-consumer, or a hybrid model, each path requires distinct contracting strategies, rebate structures, and regulatory submissions.

“Once your channel strategy is locked, it drives a whole cascade of decisions about processes and systems,” Ward explains. “Outsourcing some of that is smart but only if you know what to hold onto.”

Most importantly, when choosing a BPO, ensure their standard processes don’t limit your own policies. Don’t accept a cookie-cutter workflow if your strategy demands customization.

What to Keep In-House vs. Outsource

Even with extensive outsourcing, pharma companies must retain control of their data.

“Outsourcers are stewards of your data, not owners of it,” Ward emphasizes.

Keep In-House:

• Raw data access (chargebacks, claims, sales feeds)

• Business rules and policy definitions

• Gross-to-Net strategy and validation

• Government Pricing policy and oversight

• Governance and approvals

Outsource:

• Data aggregation

• Government pricing calculations

• Chargeback and rebate processing

• Operational report generation

“You can’t manage what you can’t see,” Ririe adds. “Retain the pieces where judgment and speed matter most. Let your BPO handle the repeatable mechanics.”

While this might sound sensible, engaging with an objective trusted advisor can also be important to ensure setup of the BPO arrangement formally defines services, roles and responsibilities in a way that meets the needs of your company.

Post Launch Considerations to your Current BPO Relationship

Pharmaceutical Manufactures, especially Emerging Pharm Companies, should always reevaluate operation decisions including their BPO (Business Process Outsourcing) partner post launch. You should revisit your partnership and insource/outsource decision one to two years after launch. First, you should evaluate your partner’s performance to ensure they are consistently meeting your agreed upon expectation for delivery and service. Additionally, company growth and sustained success after launch are great times to reconsider prior outsourcing decisions and ensure they meet your current needs.

You should be asking yourself these questions about your BPO relationship:

1. Is my BPO vendor fulfilling the services they’ve been hired to perform?

2. Does my organization have the right level of visibility into process inputs, outputs and results to: a.) properly assess BPO performance? b.) readily answer business questions using the data from BPO processing?

3. Based on the answers to items 1-3, does our contract and/or statement of work with the BPO require updating?

4. Did or will our channel strategy change for our current product?

5. Are we adding products to our portfolio that will cause us to reconsider our current approach or financial commitment?

Current BPO Performance

What to Look For: Signs It’s Time to Reassess

A BPO relationship can unravel slowly or all at once. Here are the most common red flags:

• Poor Communication: Delays in responses, unclear answers, or broken feedback loops.

• Missed Deadlines: Late government filings or payment processing can trigger penalties or fines.

• Inaccurate Reporting: Misaligned data or reports that don’t reflect actual performance.

• Lack of Visibility: You don’t know what’s happening behind the scenes or can’t access raw data.

• Reactive Service: They "do what’s asked" but offer no proactive insights or improvements.

“Sometimes the relationship just needs a process reengineering — better approvals, more transparency, more ownership,” said Ririe.

How to Evaluate (and Fix) a BPO Relationship

Instead of immediately replacing an underperforming partner, consider conducting a structured operational assessment. Start by asking:

• What data am I receiving? Can I trace it back to the source?

• Are reports timely, complete, and aligned to the questions I need answered?

• Are rebate payments accurate and properly validated?

• Are government submissions on time and compliant?

If the answer to any of these or similar questions is "no," the issue may be fixable — with support. An independent third party, like Pharosity, can help redefine approval workflows, revalidate processes, and reestablish expectations.

Organizational Change

Whether your launch didn’t unfold as expected, your strategy has shifted, or your organization is growing with an expanding portfolio, these are all valid reasons to reassess your current BPO partnership.

Launch Results May Require Adjustment

When launch performance, positive or negative, doesn’t align with expectations, it often prompts a reevaluation of patient access strategies. Changes to distribution, channel mix, or payer approach can quickly create misalignment with your existing BPO agreement or your BPO vendor’s capabilities.

Examples of strategy-driven changes that may necessitate reshaping your BPO model include:

• Expanding contract strategies to new customers or channels

• Adding distribution partners or alternative delivery models

Each new customer contract increases payment, invoicing, and data complexity, while also impacting government pricing. The question is: can your current BPO partner manage these changes effectively both operationally and financially?

“Every company’s assumptions at launch are wrong to some degree,” says Ward. “The key is knowing when and how to adapt.”

Portfolio Growth

As emerging pharmaceutical companies expand their pipelines and prepare to commercialize additional assets, it often becomes necessary to reassess the current BPO relationship. Increased scale and complexity may stretch whether your existing arrangement can fully support the demands of a broader portfolio.

Growth May Require a New Balance

While your current BPO arrangement might have worked for a single product may not scale across multiple assets. With each new product comes added demands in contracting, distribution, data management, and compliance. This raises the question of which functions should remain in-house and which should be outsourced.

Examples of portfolio-driven changes that may require rethinking your BPO model include:

• Expanding patient services across therapeutic areas

• Increased complexity in contracting and government pricing

• Additional distribution partners and data integration needs

Balancing internal capabilities with outsourced support is key to ensuring scalability, while maintaining quality, compliance, and cost efficiency.

“As companies grow their portfolios, the same playbook rarely applies,” says Ward. “The challenge is building a model that adapts without breaking.”

Don’t Fear Change. Plan for It.

BPO relationships should evolve. As your product matures, new indications launch, or patient access channels shift, so must your operational model.

“If something doesn’t feel right, don’t let the fear of change hold you back,” says Ward. “You don’t always have to break up — sometimes you just need help fixing it.”

Our team has helped many manufacturers manage their evolving relationships with many different BPOs. Contact us to chat pharosity.com/contact.