Navigating New Frontiers: Deep Dive into the CRO Landscape in Emerging Markets

The global pharmaceutical industry has experienced rapid growth in the past two decades, and the global pharmaceutical market size is expected to increase at a compound annual growth rate (CAGR) of 6.15% between 2024 and 2033. This forecast provides insights into the increasing pressure on drug manufacturers. Today, drug manufacturers face pressure from extrinsic factors such as stricter regulatory requirements, a competitive generic drug market, patent expirations, and increased public scrutiny.

To combat the effects of these factors, drug manufacturers have opted for different routes. Some are using generative artificial intelligence (AI) tools to discover new structures, reducing the cost of research and development. Others are integrating AI models, such as Trial Pathfinder, Criteria2Query, and Trials.ai, to simplify clinical trial development and performance. However, among these various methods is the CRO phenomenon, which we believe is the most interesting.

Contract research organisations (CROs) are not new in the pharmaceutical sector, but they have been gathering considerable attention in the past year. Hence, it is necessary to dissect this new frontier to understand the roles CROs are expected to play in emerging markets. So, let’s break it down.

What are CROs?

A contract research organisation (CRO) is a third-party company that provides services and resources to pharmaceutical, biotechnology, and medical device companies as well as research institutions, universities and government organisations (called sponsors). CROs offer various services; however, the most common ones include clinical trial planning, site selection and initiation, recruitment support, clinical monitoring, trial logistics, biostatistics and data management, regulatory affairs, medical writing, and project management.

Sponsors who want to run clinical trials for their developed drug or medical device but have limited resources and cannot support the extensive clinical trial requirements often hire CROs. By hiring CROs, sponsors no longer need full-time staff to complete projects. Instead, CROs are hired on a project-by-project basis and are given autonomy to plan, coordinate, execute and manage clinical trials according to the sponsor’s requirements. Consequently, the CRO oversees all aspects of clinical trials; it communicates between the various stakeholders (participants, regulatory personnel, ethics committee, vendors, research coordinators, etc.) and ensures regulatory compliance throughout the process.

Simply put, CROs range from international full-service organisations to niche speciality groups. They offer sponsors the chance to move their drug or medical device from conception to regulatory approval without hiring full-time staff.

Why are sponsors outsourcing clinical trials to CROs?

Pharmaceutical and biotechnology companies face several challenges during clinical trials, which impact the company’s efficiency and success. These challenges include:

Site selection

The site of clinical trials significantly impacts their success or failure. When selecting sites, companies must consider patient access, infrastructure, site experience in clinical research, suitability for treatment, ethical concerns, etc.

Patient recruitment

Even though AI tools such as Deep6 AI have shown significant promise in matching upcoming clinical trials with potential participants, patient recruitment is still time-consuming and expensive for companies. Furthermore, creating a patient group that adequately represents people from various ethnicities, ages, genders, and socioeconomic backgrounds Is time-consuming.

Regulatory landscape

Securing approvals and adhering to regulatory requirements are significant hurdles for a company, especially considering the evolving guidelines. It increases the complexity of clinical trials and requires coordination among multiple partners, sites, vendors, etc.

Data management and quality

Companies must focus on clinical trial data’s accuracy, integrity, and efficiency. However, modern clinical trials generate hundreds of data points. For example, devices like smartwatches (generally used to obtain real-time patient data) can generate 1 million data points per patient daily. The management and analysis of this data are challenging.

All these factors result in one thing: high costs. Companies have to work with multiple partners patiently, use enormous resources, and allocate considerable budgets to see the success of their clinical trials, which does not seem economically feasible. Consequently, CROs are hired to fill in the gaps.

But how do CROs solve these challenges?

Site selection

CROs can leverage their geographic, demographic and clinical trial expertise to optimise site selection. This is a considerable advantage when sponsors require international clinical trials because the CRO can manage site selection across regions, ensuring all criteria are met.

Patient recruitment

CROs follow agreed-upon recruitment plans, ensure diverse participant pools and obtain informed consent before starting trials. CROs often partner with local and international healthcare providers and engage in patient communities to find participants for clinical trials. Furthermore, CROs also use technological advancements like AI tools to recruit suitable participants.

Regulatory landscape

CROs have dedicated teams for regulatory compliance. These teams ensure the clinical trials comply with regulatory requirements and good clinical practice (GCP) guidelines. They also support sponsors for regulatory submissions and communication or complete these processes on the sponsor’s behalf.

Data management and quality

CROs employ sophisticated data management systems to ensure the accuracy and efficiency of clinical data. These systems also implement quality control measures, conduct validation, and adhere to regulatory guidelines. They also integrate the latest technological innovations to ensure accurate data processing and analysis.

These, in turn, are advantageous for the sponsor, who can hire a CRO and complete a mammoth task. CROs offer various advantages to sponsors:

• They have professionals with extensive experience in clinical trial design and execution.
• The pharmaceutical company can focus on other projects while outsourcing the clinical trials.
• Many CROs have an international presence, ensuring clinical trials can simultaneously be conducted across various regions.
• CROs usually focus on clinical trials, which means the focus remains on obtaining high-quality data and ensuring patient safety.
• CRO partnership allows considerable savings for the sponsor, who can allocate this budget to other projects in the pipeline.

What type of contracts do CROs offer?

Milestone-based fixed-price contracts

These are the most frequently used contract types in clinical research projects. Under this contract, the CRO quotes a fixed price for completing agreed-upon milestones, such as 50% patient recruitment. These are generally used when the scope of work is very well defined.

Variable-price fixed-unit contracts

Under these contracts, the total price of a unit may vary from one contract to another, but a fixed price is decided for all units. For example, a CRO providing regulatory submission service may charge $X per submission. These are generally used when the scope of work is undecided or depends on different study milestones.

Time and material contracts

Under time and material contracts, the CRO bills the sponsor for the hours worked and materials used at a pre-decided rate. For example, a CRO may quote $50 per hour of work, and the sponsor must pay the invoice for the total hours worked according to this rate. These contracts are generally used when the scope of the project is undecided.

Fee-for-service contracts

In this type of contract, the CRO provides a quotation for well-defined services such as a literature review or synthesis of a reference compound. The sponsor is charged only for this service and has to pay additional charges (or create additional contracts) for more services.

Full-time equivalent (FTE) contracts

In this type of contract, the sponsor company hires a project team at the CRO premises and pays for all expenses. The project team works only on this sponsor’s projects. The sponsor is billed for all project expenses and materials. This type of contract is generally used when there is flexible but continuous work.

So, how do you choose the right CRO among so many contract types?

How do you choose the right CRO?

Step 1: Determine your requirements.

Generally speaking, CROs are divided into three:

• CROs that conduct preclinical and non-clinical research but not clinical trials.
• CROs that conduct preclinical and non-clinical research and clinical trials.
• CROs that conduct only clinical trials.

Therefore, the first step is to determine which of these is required. The requirement varies from one project to another. If the sponsor aims to outsource only clinical trials, it should focus on CROs specialising in them.

Step 2: Evaluate potential candidates.

Several CROs are offering the services a sponsor desires. Therefore, it is necessary to evaluate each using specific criteria. For example, the CRO’s experience in research, reputation, success rate, network, global reach, and capacity need to be considered before hiring.

Step 3: Determine the contract type.

As highlighted in the previous section, CROs offer various types of contracts. Therefore, before approaching a CRO for a project, the project scope, timeline, and budget need to be decided. Internal discussions among key stakeholders are required to ensure everyone is on the same page. The contract type can be selected depending on the project scope and budget.

Step 4: Get and compare quotations.

Sponsors should often obtain quotations from several CROs before selecting one. Price should not be the key factor in deciding on a CRO. Instead, sponsors should consider other variables, including the CRO’s expertise and capability to complete the project.

Step 5: Execute the project.

Once all documentation is complete, the project can be started. The sponsor can expect regular feedback and updates from the CRO.

Hiring the right CRO for a project is that simple. Here are some Top CROs in the industry in 2024:

Top CROs in the industry

IQVIA

Founded in 2016, IQVIA is the largest CRO in the world and a leading provider of advanced analytics and clinical research services. IQVIA’s services include development plan, execution of Phase I to III of clinical research, regulatory submission, and post-marketing studies. It allows sponsors to accelerate their clinical trial site identification by 46%.

Parexel

With 35+ years of experience, Parexel offers Phase I to IV clinical development services to speed up the drug approval process. Within the past five years, Parexel has completed 350+ clinical projects and has enrolled 114,000+ patients in clinical trials. They have a network of 45,600+ sites worldwide.

PPD

Pharmaceutical Product Development (PPD) is a CRO that offers tailored Phase I to IV clinical trial services. Their services include clinical development, product development, site management, patient recruitment, etc. They have experience in 20+ therapeutic areas and a global network of laboratories.

ICON

ICON was founded in 1990. It operates in 53+ countries and offers consulting, clinical development, and commercialisation services. It caters exclusively to biotech clients. It has an extensive network of 108 locations that sponsors can use for global clinical trials.

Medpace

Medpace is a mid-sized CRO that focuses on clinical research. With 30+ years of experience, Medpace has a network of 60 countries. Its primary client base includes mid-sized biotechnology firms, and it operates in therapeutic areas such as infectious diseases and vaccines, immunology and inflammation, haematology, and oncology.

In conclusion and outlook of CROs in the pharmaceutical sector



CROs have been around since the 1990s. However, considering the increasing pressure on the pharmaceutical sector, CROs have come into focus. The CRO market size is estimated to increase by USD 63.35 billion between 2023 and 2028, which is a CAGR of 12.61%. Outsourcing is becoming increasingly popular in the pharmaceutical and biotechnology sectors because CROs enable sponsors to streamline their operations, improve efficiency, and enhance clinical data management.

Outsourcing clinical research is particularly beneficial for pharmaceutical companies because they can focus on other projects. CROs also ensure regulatory compliance and accelerate drug development timelines, benefiting sponsors who can get the product market-ready at earlier dates.

CROs offering services like data management and clinical train optimisation and design and specialising in integral fields such as oncology are expected to come into focus in upcoming years. As the industry grows, CROs will continue to be integral partners of pharmaceutical companies, driving innovation and improving clinical trial outcomes.

FAQs

1. How do CROs support clinical trials?

CROs manage, initiate and execute studies for clinical trials, including protocol development, site selection, patient recruitment, regulatory submission, data collection and result reporting.

2. What are the regulatory considerations of working with a CRO?

When working with a CRO, sponsors should ensure compliance with regulatory standards, including good manufacturing, clinical, and laboratory practices.

3. What is the role of a CRO in regulatory submission?

CROs prepare, compile and submit regulatory documents required for clinical trial approval and drug marketing. They also ensure regulatory compliance and interact with regulatory agencies on the sponsor’s behalf.