CRO Biotech Solutions
In the dynamic landscape of biotechnology, contract research organizations (CROs) play a vital role in accelerating drug development, streamlining processes and ensuring regulatory compliance. Many smaller biotech companies are focused on one or a few compounds in a particular therapeutic area and may benefit from additional resources or infrastructure to bring their therapies to market. The lean and agile model of biotechs means they often outsource a larger percentage of their activities than mid-size or large pharmaceutical companies.
With solutions such as Functional Service Provider partnerships, CROs can help biotechs meet critical milestones in the complex journey from drug discovery to commercialization.
CRO services for biotech companies
By aligning with a reputable CRO services provider, biotechs gain access to a wealth of expertise and resources, ensuring that their assets are in capable hands. A CRO partner can:
- Integrate scientific, clinical, regulatory and commercial aspects of clinical trials.
- Implement standard operating procedures (SOPs) and train staff.
- Provide well-thought-out trial designs. By carefully planning the trial structure, including the selection of endpoints and the overall methodology, companies reduce the likelihood of costly delays or the need for additional trial arms. Careful planning can also potentially reduce the burden on patients.
- Manage regulatory submissions and global compliance.
- Monitor and evaluate the safety of the investigational product throughout its lifecycle, including during clinical trials and after approval, and manage adverse event reporting and other safety-related activities.
- Implement targeted recruitment and patient engagement strategies to reduce dropout rates, keeping the trial on track and within budget.
- Identify and monitor clinical research sites, negotiate contracts and develop a site selection plan.
- Improve trial diversity by incorporating input from patients, caregivers and research site staff to help shape protocols, reduce trial burden and increase retention.
- Assist in commercial planning and positioning by clearly articulating a product value story that will resonate in the marketplace and support the biotech’s goals to make the right asset development choices, raise funds, gain market share, obtain reimbursement and accelerate commercialization.
- Deliver capital efficiency and better ROI by ensuring high-quality work and circumventing quality issues.
- Provide integrated laboratory services.
Leaning into technology and scientific insights further addresses the challenge of ensuring real-world patient populations. By leveraging digital tools and platforms, well-positioned CROs can often reach a broader range of patients, including those in underrepresented communities.
Addressing biotech-specific challenges
Biotechnology companies often operate with leaner teams, focused resources, and streamlined budgets compared to larger pharmaceutical companies, which can dedicate extensive personnel and technology to accelerate trials. Despite these advantages, many pharma companies also engage CRO service providers, either through full strategic partnerships or targeted collaborative models, to further enhance trial efficiency. Therefore, biotechs must strike a balance between efficient resource allocation and the intricacies of drug development, including time and cost considerations, patient recruitment and varying regulatory requirements by country.
While established pharma companies have the option to build best-in-class capabilities in-house and outsource selectively, biotechs—given their rapid growth and scaled down development infrastructure—often must rely on CROs to provide the full offering of clinical services before they can consider building out their own development organizations.
Additionally, biotech companies are often in the process of building their global reputation. In interactions with clinical trial sites, investigators, patients, caregivers, key opinion leaders, regulatory authorities, investors and other stakeholders worldwide, biotech companies may benefit from the extended networks and established relationships that global CRO partners bring, offering connections and expertise across many countries.
Innovation in clinical development often necessitates working with specialized vendors offering best-in-class solutions, from electronic clinical-outcome assessments to trial payments and decentralized or virtual trials. While contracting with several of these vendors individually may yield the most advanced clinical trials, it also requires sophisticated vendor management capabilities and processes that are challenging for many emerging biotech companies to manage without the support of an established CRO that can provide comprehensive services.
From a financial perspective, biotech companies must often address funding questions not faced by larger pharmas. In recent years, biotechs have had to adjust their approaches to securing funding amid a much more competitive market for investment funding. Private investment has become highly selective, requiring clearer demonstrations of value and utility from the outset.
Biotechs may also be subject to transitions via mergers and acquisitions (M&A) with larger companies. Large pharmas have long relied on biotechs to augment their development pipelines, but they lean toward high- quality, proven assets (e.g., drugs that are already in Phase III trials).
Biotech funding is typically raised from venture capitalists (VC) and sometimes “angels” and venture philanthropies. In the standard biotech funding model, a company founder comes up with an idea and obtains some preliminary scientific results, then takes the data to investors or VC firms for financial backing for the project. Additional funding rounds could be tied to later development milestones.
The benefits of CROs for biotech companies
By leveraging the expertise and resources of CROs, biotech companies can overcome challenges and achieve their goals more efficiently. The benefits include:
Streamlining clinical trial operations
CROs possess extensive experience in planning, executing and managing clinical trials, which can help biotech companies optimize trial design, patient recruitment and data collection processes. Tapping into their vast networks and operational expertise, global CROs can accelerate trial timelines, reduce costs and enhance data quality.
Providing specialized expertise
With lean budgets, biotech companies may benefit from specialized expertise to support successful drug development. CROs offer access to a diverse team of professionals with specialized knowledge in areas such as pharmacology, biostatistics and regulatory affairs that can complement the biotech’s capabilities and allow it to focus on its core competencies.
Data management and analysis
Effective data management and analysis are essential for biotech companies to derive meaningful insights from clinical trials and make data-driven decisions. CROs employ advanced technologies and data management systems to collect, analyze and interpret complex data sets. They ensure data integrity, facilitate efficient data sharing and employ statistical methodologies for accurate analysis.
Regulatory support and quality assurance
Navigating regulatory hurdles is a critical aspect of drug development. With their thorough understanding of regulatory guidelines and experience in dealing with the relevant authorities, CROs can provide guidance to biotech companies throughout the process. Their in-depth knowledge of regulatory requirements can help mitigate risks and ensure compliance, minimizing delays and maximizing efficiency.
Accelerating time to market
With their knowledge of international market trends, CROs can provide valuable insights and support in developing market access strategies for biotech companies, conducting market research, assessing competitive landscapes and providing guidance on pricing and reimbursement strategies. CROs help biotech companies understand market dynamics, target the right patient populations and position their products for introduction into the marketplace more quickly.
Key strategies for biotech startup success
To interest investors, biotech startups must have a demonstrated and viable path to the patient. Successful biotechs should be very grounded in product opportunities that can be supported by partnerships with CROs. Biotech companies can secure future growth and address market challenges by establishing such beneficial alliances, leveraging technology such as AI and focusing on capital allocation.
Expanding the biotech sector bandwidth for drug discovery
The future of drug discovery in biotechnology is dependent on scale, speed and cost efficiency. One area that is fueling this transformation in drug discovery is generative biology, the pairing of artificial intelligence (AI) and machine learning (ML) with innovations in biology and the lab.
A new wave of drug development platforms, enabled by AI, is helping biotech companies use vast data sets to quickly identify patient-response markers and develop viable drug targets more cost-effectively and efficiently. The results could be transformative, not just for medical providers and patients suffering from hard-to-treat diseases, but for the biotech sector as a whole. Morgan Stanley Research reports that modest improvements in early-stage drug development success rates, enabled by the use of AI and ML, could lead to an additional 50 novel therapies over a 10-year period, which could translate to a $50 billion opportunity.
FAQs
What is the role of biotechnology in clinical research?
In clinical research, biotechnology involves the use of living organisms and biological systems to create products that improve human health. Some common biotechnology applications include the development of new drugs and therapies, personalized medicine, cell and gene therapy (CGT) and the production of vaccines and diagnostic tests for various diseases. For example, in the area of CGT, recent advancements in biotech have allowed for more accessible DNA sequencing, speedier DNA synthesis and more accurate gene-editing tools.
When and why would biotech companies use CROs?
CROs offer biotech customers a cost-effective drug development partner. Instead of hiring trial experts in-house to arrange for patient enrollment, clinical data management and other responsibilities associated with documenting an investigational drug’s safety and efficacy, many biotechs outsource these tasks to a CRO. CROs provide specialized capabilities, skilled personnel, infrastructure and technologies that can alleviate operational challenges for biotech companies. CROs can also help biotechs by acquiring capabilities in key innovation areas, offering outcome-based contract arrangements and developing a flexible, concierge-like model of clinical development support, including trained personnel.
More than a third of biotech respondents in our 2024 report, The Pulse: Global R&D Insights in Pharmaceuticals, are struggling to find vendors with sufficient scientific and therapeutic expertise. As a result, 41% have increased their reliance on CROs through Functional Service Provider (FSP) partnerships.
Our biotech services solutions
As clinical trials become larger and more complex, biotech organizations are outsourcing a greater percentage of related services. They are looking for flexible, responsive partnerships with CROs that have the breadth and depth of capability to help them achieve their long-term goals.
We make the road to success easier. Our combination of clinical trial and CDMO services can accelerate your journey to market. PPD Biotech solutions brings you end-to-end capabilities and greater clinical trial reliability and quality, while simplifying your drug development path.
