Assessment Of The Contract Research Organizations Commerce Essay

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History has shown us that throughout the years the clinical contract research industry grew at a remarkable rate. There are two reasons that led to the growth of contract research organizations. The first reason is that the pharmaceutical and biotechnology industry in the Unites States and throughout the world underwent a transition that included strategic use of outsourcing in drug development. The second reason is that contract research organizations responded to this demand through providing newly innovated leadership training (Mclaughlin & Kauluzny, 2006). CRO's have developed sound scientific procedures that emphasize customer satisfaction.

Healthcare organizations have contracted clinical research organizations to research pharmaceutical industry trends. The development of a new pharmacy product is time consuming and very expensive. When CRO's are developing a product they, must ensure that the product passes the drug development process. The average time for clinical development is ten years for two companies to less that three years for one company. CROs first showed up in the bio-tech industry in the late 1970s and quickly took on a significant role in research and development (R&D), eventually expanding from drug discovery and preclinical work to clinical trials, drug manufacturing, and even marketing (Akst, 2009).

According to a 2005 Thomson Center-Watch survey, the $15 billion CRO industry was growing at a rate of 12% each year, but data from the past two years show a substantially higher annual growth rate of nearly 17%. In 2007, of the approximately $60 billion bio-tech and pharmaceutical companies spent on drug development, $15 billion (25%) was outsourced. Last year, despite the economic recession, the CRO market grew to nearly $20 billion -- 29% of the $74 billion drug development budget (Akst, 2009).

Customer service is one of the most important factors when dealing with the continuous quality improvement process. Health care professionals are responsible for ensuring that patients are satisfied with the services and products that have been provided. It is important that providers receive feedback from their patients. Feedback can be done in many forms. The use of surveys is the most common form. Surveys will enable managers to collect data on patients that participated in clinical trials and determine what input they may have on the process. Providers and the clinical research team will analyze the surveys and adjust the clinical research process to improve customer service.

CRO should be customer driven and focus on fighting diseases where common drugs are not effective. These organizations can implement policies and procedures that will ensure customer are provided with clinical research products and testing that will expose them to minimal risk. One of the processes for minimizing the risk is to carefully evaluate companies that are biding for clinical research contracts. Health care organizations determine whether they are going to award new contracts to a research organization, based on a quality product, timeliness on the delivery of the product and whether or not the previous clinical trials for that product had a high success rate.

The work performed by these organizations is scientific in nature and require a high degree of technical expertise. It is critical that during the contract process that managers review the qualification of personnel that work for the contract research organization. This will ensure that an organization with the highest qualified personnel is awarded the research contract. Because of their important role in the drug development activities, typical pharmaceutical or biotech companies may perceive themselves as the ultimate customer for the work performed by CRO's. However both sponsors and CRO's are actually working to meet the needs of patients and their representative (Mclaughlin & Kauluzy, 2006).

Training and development is a critical factor when implementing a Continuous Quality Improvement plan. CRO should emphasize training so that the development of new products can be done by competent professionals. CRO managers must have a plan in place to evaluate training, so they can determine whether it is benefiting employees and improving the quality of the product. The implementation of a training plan can also enable an organization to meet their goals and established performance measures for clinical trial success. Managers will need to evaluate employees to determine whether they have a clear understanding of the research process. This evaluation will cover what they have learned during the training and development phase.

Employees should be evaluated by comparing their newly acquired skills with the skills defined by the goals of the training program. Any discrepancies should be noted and adjustments made to the training program to enable employees to meet specified goals. Many training programs fall short of their expectations simply because the administrator failed to evaluate its progress until it was too late. Timely evaluation will prevent the training from straying from its goals. Continuous learning and training, as prescribed by Deming and others, were carried out by the top management of the company and were usually driven by their vision of how CROs could provide uniquely efficient services and in the long run transform the drug development process (Mclaughlin & Kauluzy, 2006)

Patient safety is a major concern when dealing with clinical research. It is important that researchers ensure that patients will not have any major side effect that would lead to death, when creating a new drug. Patients that wish to participate in clinical trials are carefully screened. The screening process is usually conducted by a physician to ensure that a complete review of the patient's medical history is obtained. If there are any indications that might show the physician and the research team that the patient will not be able to survive the study the patient is notified that the trial can be detrimental to their health.

Clinical investigators are responsible for protecting the rights, safety, and welfare of subjects under their care during a clinical trial (21 CFR 312.60 and 812.100) (FDA, 2010). In many trials, the sponsor delegates some decisions regarding trial design and conduct to an entity such as a steering committee or contract research organization (CRO). Patient safety has always been the industry's focus during clinical trials. However, a recent spate of well-publicized patient safety issues has increased public scrutiny and the industry's desire to improve study quality, resulting in larger, longer, more expensive trials. Wen researchers have developed a plan for a new drug they would like to develop; they will have to inform clinical investigators to ensure that the product will be safe.

Leadership is an important component of the continuous quality improvement cycle. Contract research organizations must be able to maintain profitability, satisfy employees and customers. This can be done through effective leadership. Leaders within a contract research organization will need to ensure the objective of the organization are stated and understood by all employees. CRO managers are responsible for establishing mission and vision statements. These mission and vision statements are critical towards the organizations success. Leaders must ensure that they are motivating employees to accomplish the organizational goals while maintaining a high rate of patient safety.

The Brisbane Initiative (BI) is an example of establishing training to improve quality and enhance the clinical research process. It began in 2002, bringing together primary care academics committed to fostering leadership skills in early and developing career researchers, from the UK, Europe, the USA and Australia. The aim is to attract and support the most talented researchers in a senior research career. Strategies within the initiative include cooperative development of research educational resources, the development of Expert Groups and Think Tanks, fellowships and visiting traineeships, and support of small, international peer learning set cohorts aimed at postdoctoral primary care researchers. The BI model provides a structure to identify and support future leaders, building on the successes of research leaders going before them, while fostering collaborative learning across international boundaries. It also builds an important link between local, community-based research and the global discipline of primary care research (Biomedicalcentral, 2008).

Quality improvement in the clinical research field is critical towards the success of the newly developed product. Managers will need to understand that to close the gap between current and expected levels of quality as defined by standards; they must understand the basic of quality management. This core QA activity uses quality management tools and principles to understand and address system deficiencies, enhance strengths, and improve healthcare processes. A range of quality improvement approaches exist, from individual problem solving, rapid team problem solving, and systematic team problem solving to process improvement and redesign and organizational restructuring/reengineering (Qaproject, 2010).

In conclusion contract research organizations provide a vital service to the healthcare industry. Healthcare organizations are constantly looking for ways they can improve the clinical research process. The clinical research process involves a great level of attention and motivation. Managers will need to hire employees that are competent and motivated, so they can improve customer service within the organization. CRO's are implementing continuous quality improvement processes to improve the outcome of clinical trials. Clinical trials are being conducted throughout the United States, so that medical professionals can find ways to cure diseases.