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An Overview of CRO Service in Early Drug Development

clinical laboratory services

What are CRO services? 

A Clinical Research Organization or a Contract Research Organisation as it is also known as provides clinical laboratory services. These are organizations that are engaged in providing clinical trials and research support services to biotechnology industries and pharmaceuticals. 

These organizations also serve universities, government institutions, research institutions, and foundations.

The nature of these services is research-based for drugs or medical devices. In the case of new drug development, for instance, CRO services aid an organization with the development of the drug right from its conception all the way through to FDA marketing approval. A drug development company with CRO services at its disposal need not maintain a separate staff for such services.

Services provided by CROs

  • Project Management
  • Early drug research and discovery 
  • Preclinical studies
  • Clinical trials
  • Toxicology study
  • Laboratory functions
  • Bio-analytical services
  • Statistical analysis 
  • Cite monitoring services
  • Data management and database design
  • Vigilance
  • Process development
  • Regulatory affair
  • Product commercialization
  • FDA marketing

Importance and Benefits of CROs

Drug developers often face challenges when it comes to managing R&D costs, capacity, etc. when all the activities are managed in-house. With the outsourcing of a chunk of such activities to CROs, the changing needs of the drug development processes are effectively handled. This helps the development companies overcome the various initial challenges faced and speed up the drug development process. 

The new drug is discovered, it is then developed after which it undergoes preclinical testing and then the several phases of clinical trials. This process requires faultless planning, and a CRO plays a vital role with regards to all these stages.

Outsourcing activities to such organizations come with several benefits:

  • Reduced Cycle Times
  • Accelerated drug development process
  • Reduced number of repeat cycles
  • Budgeted R&D expenditure
  • Reduced operational costs
  • Improved Efficiency
  • Better decision making
  • Precision and increased potential for success

For an industry that came into existence just almost a decade ago, this sector has shown tremendous growth compared to a number of other industries. As pharmaceutical companies face an increasing number of challenges with the ever-rising development and R&D costs, 

CRO services provide a way to reduce this burden substantially. A large chunk of the funds goes in the early stages of development, especially R&D. CRO can help manages such expenditure.

By outsourcing the various activities involved in the course of drug development, the companies significantly reduce overhead costs and seamlessly manage the entire process. The existence of such organizations in itself makes the process of drug development more cost-effective. It allows companies to undertake the development of smaller drugs for niche markets. 

In the early drug development stage, a CRO provides skilled assistance right from the research study. These organizations have the know-how to manage the demanding new clinical as well as regulatory approaches. They also offer assistance with the implementation and successful completion of new drug development initiatives. 

A CRO can seamlessly monitor and manage complicated clinical studies. With excellent clinical laboratory services , a pharmaceutical company can develop new drugs even with a short time to market, with precise efficiency and safety profile and all this at substantially low operational costs.

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