Contract Research Organizations (CROs) play a crucial role in the world of clinical trials and drug development. Comprehensive CROs stand out as trusted partners, managing the entire clinical trial process from start to finish. In this article, we explain what a full-service CRO is, the services it offers, and the benefits it brings to pharmaceutical companies.

What’s a Full-Service CRO?

A full-service CRO provides comprehensive support to pharmaceutical, biotechnology, and medical device companies at every stage of drug development. Unlike niche providers, a full-service CRO offers complete solutions covering all aspects of clinical trials and development. CROs can be divided into two types:

Niche CROs specialize in specific services such as biostatistics, data management, or pharmacovigilance. While they offer a high level of specialization, working with multiple niche providers can lead to coordination issues and increased costs.

Full-service CROs are regulated by clinical trial laws and regularly audited by relevant institutions. They offer a wide range of services at every stage of the drug life cycle, including:

• comprehensive study oversight**: From planning to completion,
• creating regulatory-compliant study designs,
• support in regulatory submissions and approvals,
• initiation of clinical trials,
• patient recruitment and retention,
• site selection and monitoring, ensuring data quality,
• collection, management, and analysis of clinical data,
• preparation of key documents such as study reports and regulatory submissions,
• monitoring the safety of all study participants,
• logistics and supply chain management,
• quality control to maintain study integrity,
• regular communication with study sites, support, and protocol compliance.

Is a Full-Service CRO right for you?

The decision to work with a full-service CRO depends on the complexity of the trials, available resources, and the sponsor's strategic goals. A full-service CRO offers an integrated approach, which can accelerate trial execution and reduce costs. The benefits of working with a full-service CRO is a expertise and experience in drug development and regulatory compliance, cost-efficiency, time savings, risk minimization, fexibility and scalability, and the last - focus on core competencies.

Technology driving CRO

BioStat is a commercial research unit with the status of a Research and Development Center. As a Polish CRO, we provide comprehensive services for both commercial and non-commercial clinical trials. We specialize in Phase I-IV trials and observational studies, operating in Poland and Central and Eastern Europe. Whether you are looking for a partner to support the entire clinical development process or need additional specialized support, BioStat offers a team of experts proficient in planning, conducting clinical trials, and navigating the regulatory approval process.

Ready to collaborate with a full-service CRO? Contact BioStat today to get expert support for your clinical trials.