CRO and Supplier Procurement

Supplier procurement in life sciences, particularly within the context of Clinical Research Organizations (CROs), encompasses the strategic process of identifying, selecting, and managing external vendors who provide critical services and resources essential for the successful execution of clinical trials. These trials are pivotal in evaluating the safety and efficacy of pharmaceuticals and medical devices, making the procurement of CRO services a crucial aspect of drug development and regulatory approval processes. 

Clinical research is a complex undertaking that has the best chance of success when the sponsor organization collaborates effectively with partners. Pharmaceutical companies and biotechs often work with a contract research organization (CRO) to run a clinical trial, and this engagement can account for a large proportion of the trial’s budget. 

CRO and supplier procurement isn’t just a logistical necessity: the trial depends on the sponsor choosing the right vendors. With so many CROs around the world, this can be a daunting decision. So, how can organizations in the life sciences best choose suppliers for their research projects? 

By following a vendor selection process that focuses on the individual needs of the trial, including the risks involved, the pharma company or biotech can build a solid foundation for long-term collaboration. 

The biggest life sciences supplier contract that a sponsor is likely to need for their clinical trial is with a contract research organization (CRO). A CRO is a company that provides outsourced support to life science organizations, including pharmaceutical companies, biotechs, and medical device companies.

Life sciences CRO services vary, but many CROs offer core services and similar service models. For example, CROs are likely to offer support for aspects like trial design and startup, regulatory submission, site inspections, patient recruitment and retention, clinical monitoring, quality assurance, data collection and analysis, and medical writing and publishing. 

In terms of the models offered, CROs often provide full CRO services, where the sponsor can fully outsource management of the clinical trial, and functional service provider (FSP) models, which are more flexible and enable the sponsor to outsource certain aspects of the trial depending on their needs.

CROs aren’t the only vendors in the life sciences supply chain. Clinical trials are likely to need specialty suppliers in addition to a main CRO to cover everything from training to lab services. 

For example, life science suppliers include those who support lab work. In the lab, trials might require specialty lab equipment, reagents, and chemicals, while others might need support for histology, pathology, or genomics.

CMC Suppliers provide chemistry, manufacturing, and Control support. They specialize in sourcing essential components like drug substances, drug products, and packaging, which are crucial for the development and production of pharmaceuticals.

Logistics Suppliers offer outsourcing solutions for logistics needs such as warehousing, picking, packing, and shipping. They ensure efficient and secure transport of clinical trial materials and supplies to global trial sites.

Lab Suppliers facilitate vendor selections for specialized laboratory services. This includes central lab testing, bioanalytical services, and immune monitoring, essential for gathering and analyzing clinical trial data.

Other life science suppliers help sponsors with supply and logistics, including manufacturing and supplying drugs or medical devices for the trial. Companies can also provide services for handling biological samples, such as blood and tissue samples. 

And other specialty suppliers may be contracted to cover services CROs can also provide, such as training, regulatory support, and patient recruitment.

The specialty supplier selection biotech companies undertake can follow a similar process to that of the main CRO. In both cases, it’s important to start by understanding what the clinical trial needs and what its biggest risks are.

>>> Learn about the Effective Vendor Selection Formalized Process for Biotechs

Successful clinical trial outsourcing strategies should start with defining the trial’s needs and risks and setting out to find the right suppliers on that basis. This not only helps narrow down the choice of vendors but also gives the pharmaceutical company or biotech the best chance of finding the right suppliers.

Vendor selection can be a costly process, in terms of time and money, so it’s important to maximize efficiency. At a high level, think about things like project scope, objectives, timelines, and budget constraints. This will give you a broad framework to start with.

Then, focus on what your trial needs beyond the standard requirements. To do this, consider the biggest risks you face. Ask questions like what could happen to delay the timeline? What could happen to stop the trial altogether? These insights will highlight the services and competencies you need in your partners, which will further narrow the field of choices.

Let’s look at how quality and compliance with regulations plays a part in CRO and supplier procurement.

Some of the risks you identify in determining your trial’s needs might relate to regulation, compliance, and quality. With stringent and evolving clinical trial legislation, it is important to ensure you remain compliant.

This is also the case for tasks and responsibilities you outsource, from clinical operations to quality control. As the sponsor, you are accountable, regardless of whether you do the work directly. Accountability makes effective collaboration and oversight of partnerships even more important.

The supplier selection process is the time to start thinking about pharma vendor evaluation. Based on your trial’s risks and needs, what factors are you looking for, and where and how will you assess performance?

At the end of the vendor selection process, when you have chosen the CRO or life sciences supplier that best meets your trial’s needs, you will face the task of agreeing on what that partnership looks like. This is where the contract comes in.

It’s advisable for the sponsor to take the lead when it comes to setting out the terms and conditions and other contractual details. Doing this means you stay in control of establishing the relationship and, down the line, ongoing performance evaluation.

The CRO is likely to offer their own template contract. While this may seem like an efficient way to move forward, it’s better to use your own. When setting out the details, be sure to again consider the risks to your trial and your specific needs. Are they all addressed? Whatever contract you decide to use, ensure you read each clause carefully and make sure the contract covers all the most important aspects.

You will also need to set out a service level agreement, which the supplier or CRO may put forward, as well as pricing structures and payment terms. Budget is likely to be a major consideration, and reading the fine print, for example, on issues like inflation, is critical.

>>> Learn more about Contracts in Drug Development between Sponsors and Suppliers here.

With over a decade of experience running vendor selection processes and implementing life sciences supplier management for biotechs and pharma companies, we know how to ensure efficient CRO and supplier procurement.

From vendor selection and contract negotiation to vendor management and governance for effective oversight, our Cinical Development experts work with a range of companies, helping them find the right suppliers and optimize their partnerships.

In a three-part series of white papers, we share our insights and advice, helping sponsors avoid common mistakes at each step of the process. You can download the white papers on our website.

CRO and supplier procurement is a critical process for the success of your clinical trial. Depending on your needs, you might choose to work with a contract research organization (CRO) or more specialist suppliers covering everything from lab equipment to data analysis.

To maximize these partnerships, it’s important to follow an effective vendor selection process. Starting with your trial’s risks and needs, you can set out the requirements and points of evaluation for potential vendors. And by taking control of the contract phase, you can ensure you retain oversight and remain compliant.

>>> Learn more about How To Select Vendors here

Seuss+ can support sponsors throughout this whole process; contact us to talk about your needs and get started.