Clinical development outsourcing helps a sponsor reduce a clinical trial’s regulatory burden and financial risks. It also expands capabilities and boosts revenues. Despite the many advantages of clinical trial outsourcing, it is only for some. There are some essential things to consider before making a decision. These benefits can increase the chances of success.
The expanding capabilities of clinical development outsourcing providers are becoming an essential part of the overall clinical drug development process. The outsourcing industry has grown to include numerous companies from the biopharmaceutical and pharmaceutical industries. Some of these firms have a particular focus, such as developing novel oral solid dosage products. Some companies have also recently expanded their campuses and commercial manufacturing facilities. In addition to providing comprehensive clinical trial services, they provide single-source FDA registration for products, including generic and brand-name pharmaceuticals.
A collaboration between drug discovery organizations and clinical development outsourcing providers can provide many benefits:
- It helps improve efficiency by freeing up internal headcount for value-added activities.
- Outsourcing services providers should offer a full suite of services for their clients.
- They should engage in the decision-making process.
- The clinical development outsourcing providers must provide a competitive cost and quality service.
In addition, they should be able to offer cutting-edge solutions and innovative technological developments.
Reduces regulatory burden
Clinical development outsourcing has undergone some radical changes over the past several years, with a mix of service models now widely used by biotechnology companies. These new models help pharmaceutical companies bring life-changing therapies to market faster. However, biotechnology companies must understand which model best suits their particular needs.
This private-sector initiative is designed to improve the value and cost of outsourcing clinical trials. A company can ensure that pre-market studies meet regulatory requirements by focusing on core competency. Additionally, a company can lower its costs by selecting a lower-cost facility. A company can cut its per-trial cost by up to 16 percent by choosing a lower-cost facility.
Another example is using lean models. Some sponsors use lean models exclusively, while others use them for part of their clinical trials. These decisions are often based on the clinical trial phase, therapeutic area, region, and availability of internal resources. Some companies also choose to use cost and risk-based models when outsourcing trials.
Outsourcing clinical research and development has become a critical business tool for many large and mid-sized pharmaceutical companies. In 2005, sponsor companies spent $6.6 billion on clinical contract services and pass-through costs. This increase in outsourcing spending has outpaced the overall growth rate of global development spending – 11% annually since 2001. At the same time, these companies are mainly freezing headcounts to contain rising fixed costs.
The number of chronic diseases is increasing, and governments are focusing on improving the healthcare sector. This is driving the global outsourcing market for clinical trials. Additionally, governments and non-government organizations are focusing on improving health care and ensuring the safety and efficacy of new drugs. These efforts are assisting the growth of the pharmaceutical industry, and the demand for clinical trial outsourcing services is expected to increase.
As a result, outsourcing clinical trials can reduce costs and increase revenue. Many pharmaceutical companies are outsourcing clinical development to improve efficiency and reduce costs. The growing global pharmaceutical industry and surging R&D activities are driving the global clinical trials outsourcing market.