The Role of CROs in the Modern Biotechnology Industry

a professional in biotechnology
a professional in biotechnology

Biotech has seen tremendous growth and innovation in the past few decades. With innovations in disease detection, precision medicine, and drug development, every breakthrough in biotech technology promises a bright future for healthcare.

While this new wave of products and services promises to dramatically transform healthcare, bringing them to market requires significant time, resources, and expertise. Many biotech companies are turning to contract research organizations (CROs) to leverage their expertise and resources to navigate the complex clinical trial landscape.

Modern Biotechnology: An Overview

Biotechnology is the integration of cellular and biomolecular processes in the development of products and services, many of which improve our lives and that of our planet. Over the past few decades, we’ve seen significant biotech innovations in agriculture, industrial production, and healthcare.

Modern biotech has come a long way since the FDA approved the first genetically engineered drug, insulin, in 1982, and it’s showing great promise in both curative and preventive medicine. For example, pharmaceutical drugs used to be limited to a ‘one size fits all’ approach. However, recent innovations in biotech are paving the way for tailored medicines thanks to techniques like genome sequencing – a process that cost $150 million in 2003 but can now be accomplished for $600.

A new wave of innovation is expected in the industry, with further developments in precision medicine, thanks to tools like CRISPR, along with regenerative medicine and tissue engineering resulting from developments in bioprinting.

Biotech and Clinical Trials

There are already 250 biotechnology products and vaccines on the market. For these products to make it there, they had to undergo rigorous clinical trials to test their efficacy and ensure they were safe for humans.

The development of a biopharmaceutical product starts by identifying a potential therapeutic target, then goes through the following process:

  • Selecting and optimizing the molecules to identify the best candidate.
  • Then, researchers conduct preclinical research to determine whether the candidate is safe to test on people.
  • Once approved by regulatory authorities, the candidate has to successfully pass three phases of clinical trials before sponsors can apply to bring it to market.

From preclinical research to FDA approval, bringing a new drug to market can take up to 10 years. Approximately 70% of drugs make it through Phase I, then 33% to Phase III, of which only 25-30% qualify to apply for regulatory approval. A drop-off at each trial phase equates to a considerable sunk cost for the sponsor.

Regardless of the difficulty facing these products as they move through each stage, there’s still significant optimism in the potential of biotech. According to the EY Beyond Borders report, R&D investment in the industry doubled in five years between 2016 and 2021, from US$45.7 to US$88.6 billion.

Aside from boosting sponsor return on investment (ROI), there’s a case to be made for improving productivity and success rates in these clinical trials. Biotech pipelines are full, and society can benefit from the innovations they could bring. Of the 6,000 drugs in active development, biotechs account for 65%, with notable activity in CAR-T and NK cell therapies, gene editing, and RNA therapeutics.

We’re already seeing that innovations in biotech are speeding up clinical trials. Technologies like biosimulation allow researchers to test a molecule’s efficacy and safety without relying on lengthy (and costly) human trials for every step of the process. When analyzing the progress of clinical trials, Mckinsey and Co found that biotech assets have been transitioning through Phase I and Phase II 50% faster than they did between 2013 and 2018. This increase in speed can largely be attributed to scientific advancement, innovation, and collaboration.

How CROs Benefit Biotechnology Sponsors

While biotech companies can have a high level of technical skill and may excel in product development, they often need more regulatory knowledge and international market trends. A lack of these functions can significantly impact the success of clinical trials.

Collaborating with Contract Research Organizations (CROs) can bridge gaps in expertise and resources, allowing drug developers to focus on what they do best. From supporting preclinical research to data management and pharmacovigilance, CROs like Vial are streamlining clinical trials by providing outsourced services at every stage of the clinical trial. Here are six of the top common CRO services:

1. Clinical Study Management

Clinical study management includes handling all aspects of the clinical trial, such as protocol development, site selection, patient recruitment, data management, monitoring, and reporting. While larger organizations such as IQVIA and PPD may offer all these services, small CROs like Vial also specialize in these areas.

2. Site Management and Monitoring

A part of a CRO’s role is to focus on overseeing and monitoring clinical trial sites to ensure that they follow study protocol and all regulatory requirements. This oversight includes on-site monitoring visits, training of site staff, and resolving any issues that arise.

CROs often have an established reputation and strong relationships with key stakeholders across the clinical trial landscape, giving them an edge in areas like site management, trial planning, and general trial management.

3. Data Management

Another CRO service is to provide data management and biostatistics, including database design, data entry, and quality control. The CRO can help with specialized activities like setting up a Data and Safety Monitoring Plan (DSMP) or improving workflows with tools like eSource.

4. Pharmacovigilance

Pharmacovigilance refers to the process of analyzing data of adverse events arising from biopharmaceutical products to test their safety. CROs can monitor and evaluate the safety of drugs throughout their lifecycle, including during clinical trials and after approval. They can also manage adverse event reporting and other safety-related activities.

5. Regulatory Expertise

Navigating the regulatory landscape of clinical trials is no small feat. CROs can support biotech companies to meet requirements, including submissions to regulatory agencies and compliance with international standards.

6. Quality Assurance

CROs can provide quality assurance services, including auditing, compliance, and risk management. Clinical research services can also include the development of Standard Operating Procedures (SOPs) and staff training.

The Future of Biotechnology Clinical Trials

In summary, CROs are essential partners for biotech companies conducting clinical trials, providing valuable services and expertise. With the increasing use of technology such as ePRO (electronic patient-reported outcome), EDC (electronic data capture), and eSource (electronic source), CROs like Vial are helping to drive breakthroughs in the biotech industry.

If you’re interested in partnering with a CRO that can help you leverage the latest technologies and has the expertise to improve your clinical trials, Vial is here to help. The Vial CRO is a tech-powered CRO at the forefront of the biotech industry, offering next-generation technologies to drive breakthroughs in drug development. Contact a team member today to learn more about how Vial can help you achieve your research goals, streamline trial workflows, and save your money with fixed-fee pricing.

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