Any successful business will tell you, the key to their success is the people that make it happen!

In Life Sciences specifically, determining the optimal clinical development workforce model is crucial to the success of a project. But, in today’s rapidly evolving industry, where groundbreaking discoveries and advancements surface at an unprecedented rate, Life Sciences businesses find themselves at a crossroads, faced with critical decisions around resource allocation, risk management and cost-effectiveness. 

Consequently, one of the most pivotal questions confronting Life Sciences companies today is whether they should insource or outsource key components of their operations. This conundrum, while not entirely new, has taken on a new significance in recent years. The stakes are higher, the technology more sophisticated, and the competition fiercer than ever before.

Moreover, this decision has evolved to become more complex, now encompassing various different staffing models so sponsors can access specialized services, reduce costs and drive efficiency. In fact, some sponsors even blend models to strike a perfect balance between capability and efficiency for each unique project. 

So, the question remains: what’s the correct clinical development staffing model that will fulfil your business needs, hit critical milestones and take drugs to market? 

As always, we’re on hand to help you make the right call. While many businesses throughout the industry are increasingly leaning into insourcing their teams, let’s explore the intricacies, challenges and opportunities that define the insourcing-versus-outsourcing paradigm, guiding you to make a decision that fits your unique clinical development needs.

Firstly, who in Life Sciences has already embraced insourcing?

• Beigene 

One prominent biotech that’s undergone a significant transformation in its approach to clinical trials is oncology-focused Beigene.

For context, when Beigene first began conducting clinical trials eight years ago, they relied heavily on assistance from CROs. More recently, however, they’ve shifted strategically towards handling R&D internally.

This internal shift has come with multiple benefits, including an improved patient experience and faster enrolment after reducing both time and costs by a third. This change has also allowed Beigene to further expand its innovative cancer treatments, potentially saving the lives of millions.

In fact, since leaning into insourcing, Beigene now conducts 90% of its clinical trials in-house, supported by a holistic infrastructure that includes regulatory and medical affairs, HR, legal, finance and many other fields.

Speaking on their new working model, Melika Davis, Senior Vice President and Global Head of Clinical Operations, says, “We want to make sure we understand the needs of each country, its health authorities, as well as the patients, clinical sites and the doctors – we want to understand how patients are diagnosed and treated. The only way to do that is to have an internal capability.”

• AbbVie 

The global biopharmaceutical company AbbVie is another huge name that’s recently adopted insourcing.

To do so, AbbVie invested in an internal bioanalytical unit to support its drug development research and pharmacokinetic studies. 

By integrating these functions in-house with a centralized lab, they’ve been able to adopt earlier discoveries at the pre-clinical stage, which has boosted their operational efficiency, data integrity and cost-effectiveness. 

To continuously improve its operations, AbbVie has committed to consistent analysis that will streamline its workflow and further enhance its internal bioanalytical function. They’ve found that doing so has led to better control of data quality, lower costs, faster turnaround times and real-time knowledge sharing and troubleshooting. 

Is now really the time to shift to insourcing? 

When it comes to R&D, every penny counts! Yet the challenge facing most Life Sciences businesses today is keeping within budget, so let’s uncover some questions you might be pondering when it comes to insourcing your clinical development team. 

• Won’t insourcing be more expensive?

Actually, considering the bigger picture here, when it comes to the price tag, insourcing can be the most cost-savvy choice. That’s because by keeping things in-house, you’re able to spare the hefty costs that come with outsourcing to CROs.

And that’s not all… Insourcing is a magnet for top talent, which means you get to hang on to some of the best and brightest Life Sciences minds, even after one project (or phase) ends and you head into the next, creating a smoother, more budget-friendly operation overall.

Essentially, it’s all about that short-term cost versus the long-term gain. 

• What if I spend money insourcing an entire team, and then they leave once the project comes to completion? 

Insourcing isn’t just about filling today’s positions; it’s about nurturing your dream team for the future!

By investing in training and development and providing opportunities for career advancement, you feed a culture of growth and loyalty where employees tend to stick around.

This doesn’t just mean you save big by avoiding constant hiring expenses (even for external teams). It also leads to higher levels of expertise and efficiency at your fingertips, which is often more cost-effective in the long run.  

Think of it as tending to a flourishing garden – water it, and your plants (or employees) will thrive!

• What happens if the project hits a roadblock?

In-house teams can be incredibly efficient when your project is on a roll, but what happens if it hits a speed bump? You might be left with a team that doesn’t have much to do, unlike with CROs, where you can quickly scale down or end project engagement.

We all know R&D can be a rollercoaster ride with its ups and downs. That’s why it’s vital to future-proof your business by having contingency plans in place, ensuring staff motivations and project costs remain in check.

For example, when things don’t quite go to plan, such as clinical trials are unsuccessful or investment gets pulled, you can put contingencies in place that mean freelance employees’ contracts will be terminated, and permanent employees will go back to the drawing board, which leads us on to our next point…

• What if I need to scale up or scale down a project?

Insourcing doesn’t have to be black and white. In fact, an increasingly popular strategy is to create a blended team, leveraging the strengths of permanent staff with flexible contract hires.

Your in-house team can steer the ship when things are smooth sailing, while contract hires provide agility when things get rocky. This offers stability between the cost-efficiency of insourcing and the flexibility of outsourcing.

To read more about the benefits of Life Sciences contractors, head over to our guide, Clinical Development: 7 Reasons Why Contract Solutions Can Make The Most Sense.

• Isn’t outsourcing to CRO partners just more manageable and more cost-effective?

CROs have proven themselves to be a leading force throughout the Life Sciences industry, and while they offer enormous advantages, there is one caveat – the expense.

Choosing to outsource each stage of development to a CRO means you’re essentially dividing your project into multiple components, each handled by a different external entity. Of course, this can provide top-tier expertise for each phase but also significantly drives up costs.

What’s more, managing multiple CRO relationships can be complex and time-consuming, often requiring additional resources and overhead costs. These kinds of expenses quickly add up, eroding the cost-saving benefits initially associated with outsourcing.

How will insourcing your team impact your control and oversight of a project?

When it comes to outsourcing, day-to-day visibility in your clinical development can be challenging to keep hold of even though, regardless of outcome, responsibility always finds its way back to you. Let’s dive into some questions about how to best maintain oversight and control within your clinical development.

• Will I have more, less or the same involvement in daily operations with an insourced team?

Having an in-house team puts you in the driver’s seat. It means you have direct management and active involvement in daily activities, making real-time decisions and ensuring all the project’s work aligns with your expectations and budget – even as the project needs change.

Speaking of expectations, having a close eye on the day-to-day also means you can oversee the work being done, ensuring it aligns with industry standards and regulatory requirements.

• How does insourcing impact the communication of project needs?

Teaming up with a CRO generally means entrusting a chunk of your project management to an external crew. While CROs bring a wealth of know-how to the table, they can sometimes blur your view of what’s happening.  

That’s because more players mean more chances for your messages to get tangled. As a result, being a step or two removed from daily operations and decision-making could lead to hiccups when it comes to the goals, timelines and expectations.

With an internal team, you have a direct line of sight, meaning you can ensure the project aligns precisely with your vision.  

• What impact, if any, will selecting an insourced team have on the project’s development?

One significant difference between insourcing and outsourcing is your control over the teams assigned to your project.

When you go down the CRO route, you often don’t have much influence over who will be driving your project. That’s because CROs have their own recruitment methods, and your preferences might not carry as much weight as you’d hope. This lack of influence can raise eyebrows about whether the assigned team truly fits your project’s unique needs.

On the other hand, when you decide to insource, you determine who you’ll be working with. Essentially, you hand-pick your dream team, each with unique skills ready to conquer your clinical research challenges and take your R&D to the next level.  

Does insourcing really attract top-tier talent?

It goes without saying that you want the best and brightest Life Sciences minds working on your project and steering you toward success (who doesn’t?!). With that in mind, let’s dive into questions you might have about securing the crème de la crème of Life Sciences talent.

• Isn’t the best clinical development talent already snapped up by CROs?

Like the rest of us trying to navigate current market challenges, CROs are also keeping an eye on their expenditure. For them, that means sometimes outsourcing part of their work to lower their costs.

While this can save CROs money, it might compromise other areas of your talent strategy. In fact, it could even mean lower-cost, less experienced professionals end up on your projects, which could lead to quality, efficiency and industry standards taking a hit.

By cutting out the intermediary and hiring the most qualified and suitable Life Sciences talent directly, you can expect shorter project timelines, improved efficiency, and better-quality work. Ultimately, this leaves you with a more successful project overall.

• Why would talent want to move in-house?

Many professionals within the Life Sciences landscape dream of working directly for the end client (a pharmaceutical or biotech business is the ultimate goal for many). That’s because it offers a sense of ownership, aligns them with the company’s mission, gives them a deep understanding of the product life cycle, and ultimately, allows them to feel like a real hero by being a part of the organization that brings groundbreaking therapies to the public!

Until now, however, an industry-wide trend has seen a lot of major pharmaceutical and competitive biotech companies farming out their work to CROs. That means a significant portion of job opportunities lie within the CRO world.

This can still result in valuable roles and opportunities for candidates. But for sponsors, it can result in missing out on the very best Life Sciences talent on offer, as they’re often prioritized for larger-scale operations, meaning they might not directly impact your project.

• How can I be sure talent won’t return to contracted work?

You can never be 100% sure, but for one thing, Life Sciences professionals are often driven by a deep passion for making a tangible impact on the entire life cycle of a drug, from research and clinical trials to regulatory approval and post-market activities.

When candidates work in-house at a pharmaceutical or biotechnology company, they’re given a chance to touch every stage of R&D, influencing decisions, working across different teams and witnessing their contributions shape the journey of a drug from concept to patient delivery.

In contrast, when working at a CRO, their roles tend to be more specialized, focusing on specific project phases with limiting engagement in the complete journey. In short, they can still be incredible at what they do, but they can sometimes miss the bigger picture.

Taking these candidates in-house can positively impact your business. How? Because this environment is a catalyst for innovation. It enhances efficiency and cohesion, allows for more informed decision-making, ensures quality control, minimizes knowledge loss and motivates the workforce, which only helps attract and retain a strong candidate pool – a recipe for long-term success in such a competitive market! 

Conclusion 

Every business is different, and finding the right staffing model is a critical choice that shapes the rest of your scientific journey. 

On the one hand, insourcing provides a wallet-friendly structure, nurturing talent in-house and cultivating a loyal workforce. However, a solid backup plan must be in place in case of project roadblocks. 

On the other hand, outsourcing delivers specialized expertise with all the proper infrastructure, but it can inflate costs and result in communication tangles. 

While we are seeing a shift throughout the industry, it’s fair to say that the insourcing vs. outsourcing puzzle is one that is multifaceted and changes with the tides of the market. Success lies in the balance of a business’s ability to align its approach with its goals and adapt to the ever-evolving demands and challenges of the Life Sciences industry.  

Ready to map out a hiring strategy that suits your unique business needs? Whether you want to insource, outsource or blend the two, that’s what we’re here for! Reach out to clientservicesglobal@peoplewithchemistry.com to find a workforce solution that steers you towards even greater success.