What is a CRO?

The Core Engine: What CROs Do

Figure 1: Services Offered by CRO-ZENOVEL

• Preclinical Research: Helping to establish safety by conducting toxicology, pharmacokinetics, and laboratory studies before human trials commence.
• Clinical Trial Management: The central aspect of CRO activities: developing protocols, selecting sites, recruiting patients, monitoring performance, and managing pivotal data collection.
• Regulatory Affairs Expertise: Understanding the global complexities of regulations (FDA, EMA, national) and being prepared to make key submissions (IND, NDA).
• Biostatistics and Data Management: Ensuring that trials are statistically rigorous, the data are rigorous, accurate and managed properly.
• Post-Market Surveillance: Trailing the safety and effectiveness of a drug post-approval.

Here’s why partnering with a CRO is non-negotiable:

Figure 2: Zenovel’s Operational Efficiency

• Global Reach, Localized Expertise: Globalizing trials require an understanding of where the trial is located. CROs have those local connections regarding regulations, ethics, and patient populations to optimize trail site activation time. Improve enrollment, and drive more quality data.
• Mitigating Risk: Tightly complying with rigorous international standards (e.g. ICH-GCP) local regulations. CROs, uphold the compliance standard.
• Access to Specialized Talent:  CROs can tap into the vast array of personnel with experience in niche therapeutic areas (e.g. oncology, rare disease), adaptive trial design, and decentralized/hybrid trial implementation, and the latest in data science – competencies typically too specialized for any one sponsor.
• Operational Scalability: Supports any size of project, from an early First-in-Human (FIH) study to a global Phase III trial – allowing you to engage your clinical site teams flexibly and without overwhelming your internal costs.

Partnering with the right CRO – ZENOVEL delivers concrete advantages:

• Accelerated Timelines: Standardized systems, experienced teams, and ready infrastructure accelerate the time from concept to market, ensuring faster delivery of treatments to patients in resource-lean biotechs.
• Deep Expertise & Specialization: Access to specialized knowledge repositories, such as therapeutic insights and regulatory nuances, can prevent costly mistakes and unlock opportunities that sponsors may miss internally.
• Global Infrastructure: Utilize global clinical sites, investigators, and partners to facilitate diverse patient recruitment and multi-region studies without constructing costly new internal capabilities.
• Flexibility & Scalability:  The software allows for easy adaptation to the unpredictable nature of drug development, allowing for the scaling of data processing, analysis, and operational scope as project requirements change.
• Cost Efficiency: CROs offer a more affordable solution by distributing costs across clients, reducing the significant capital expenditure required for full internal R&D, preclinical, clinical, and regulatory capabilities.
• Streamlined Regulatory Navigation: The provision of expert guidance in intricate global regulatory environments ensures swift submissions, prevents costly delays or rejections, and mitigates legal and reputational risks.

Choosing Your Strategic Ally: What Matters Most

• Proven Therapeutic Experience: A strong track record in your specific disease area, and Zenovel has more 19 years of experience
• Global Capabilities with Local Knowledge: Infrastructure spanning key regions combined with deep understanding of local regulations and practices. Zenovel has global range and experienced staffs with niche knowledge.
• Operational Excellence: Robust project management, transparent communication, and reliable timelines.
• Commitment to Quality & Safety: An unwavering focus on data integrity, patient safety, and regulatory compliance.
• Transparency: Clear pricing models and open collaboration.

CROs: Catalysts for the Future of Medicine