Clinical Research Organization Business - Essay Example

? EXECUTIVE SUMMARY by Executive Summary Within the United s, at least 38,000 clinical trials are open for patient enrollment. With numerous parties enrolled in clinical development, it is no wonder that clinical trials last longer than expected. Industry executives express concern and necessity to increase the quality of clinical trials and resolve the existing challenges, including delays in obtaining data, the lack of richness in clinical data, patient drop offs, and the rising costs of clinical trials. Potential customers are Clinical Research Organizations, which cooperate with and provide services to pharmaceutical companies. The pharmaceutical market is declining, and CROs are pressured to reduce their fixed operating costs and refocus their business, through manpower consolidation, divestiture, and better infrastructure. The coming years will witness increased participation of CROs in clinical research activities, and further expansion of pharmaceutical market will create new opportunities for entry. Quintiles, Icon, and Covance are the three largest Clinical Research Organizations in the world and currently account for one-third of the world’s market. ICON is a global contract clinical research organization, which serves the needs of pharmaceutical companies and specializes in developing and managing strategic programs to support clinical research and development. Quintiles is a pharmaceutical services provider and is currently the most influential organization in its field. The company operates in more than 60 countries and employs a total of 22,000 workers. Covance is one of the leaders of the clinical research field, which provides pharmaceutical companies with a wide range of drug development services. Charles River Laboratories specializes in pre-clinical and clinical laboratory service provision for pharmaceutical companies. The product is a software application, built on a smartphone and designed to increase the quality of data obtained and processed during the clinical trial. The application is supplied to patients participating in the clinical trial. The product comprises a number of functions, including My Calendar, My Locations, My Questions, My Meds and My Rewards. The application assists in defining those patients who are appropriate for the trial and functions as a communication instrument between patients and investigators. The tool involves the use of the RXHub National Patient Health Information network and takes advantage of smartphone video and camera opportunities. Customer experiences play a critical role in the development of the future product. With this in mind, another platform will be created, to allow for flexibility and adjustability of the discussed application. Clinical trial sponsors will be able to define and set the categories and functions they need in each particular situation. Selection, adjustability, and flexibility will help clinical trial sponsors reveal and utilize the clinical and commercial potential of their business endeavors to the fullest. None of these pieces and elements can operate without a well-developed infrastructure. The product is not an instrument of data analysis but a business tool, creating a bridge between the data collected from patients and the data captured by the Clinical Research Organization. The product facilitates the integration of data gathered from multiple sources. Seamless integration is ensured through the use of IT of the corresponding CRO. The average cost of the application is currently between $22-48K per patient. The price for each application is charged in the following manner: (a) one-time set up fee for customization is fixed; (b) subscription fees vary, depending on the number of patients enrolled in the trial and the length of the trial (the number of months the trial lasts). Therefore, depending on the trial, the product is developed at three price points: high, medium, and low. The pharmaceutical and CRO markets are becoming more competitive. The product can readily become a source of strong competitive advantage for its users/ subscribers. Despite the growing number of competitors, the product has a remarkable competitive potential. Previous applications exhibit unique characteristics, but only the new application/ product can move CROs onto a new level of clinical performance. The core operations include development and sales. Development consists of requirements and analysis, design, development, product testing, and packaging. Requirements and analysis cover a number of activities, including capturing and analyzing product feature requirements and specifying the details of software design. The design stage involves the creation of the user interface, data interface, and business logic. At the development stage, the outsourcing partner for the software development is identified. We will contact the partner with clear expectations, quality standards, and validation conditions and timelines. IT lead of the company and the outsourced company team will be responsible for the completion of this stage of project development. Testing and acceptance implies developing and testing approximately 8-10 scenarios for each element of the application. Testing will take place in an environment similar to that where the product will be finally run. Installation CDs will be created, and the software will be made available through the website. The deployment stage involves creating installation CDs, making the software application available through the website, and doing a final test of smooth download onto the hand held. The new product will be promoted, marketed, and sold with the help of conferences and trade organizations. Participation in conferences will place our product to the forefront of business competition in the pharmaceutical market. This is one of the best ways to familiarize doctors and clinical research sponsors with the strengths and benefits of the product. These conferences will provide the space and opportunity to hire advisors for our board; the latter will guide the development, promotion, and utilization of the product. As part of the sales strategy, we will seek the FDA’s endorsement for the use of the platform in the conduct of clinical trials. FDA consultants will be hired, to guide product development and deployment efforts. A senior sales executive will be hired, to assure maximum exposure of the product to customers. Small pharmaceutical companies will become one of the main targets in our sales strategies. Brand recognition will be increased, through partnering and sponsoring academic research events. Sales representatives will be primarily responsible for sales and technology promotion. The research community will be informed and educated about the benefits and advantages of using the new data management platform. The project is delivered and implemented under the leadership of John S. Whigley (Chief Executive Officer) and Warren B. White (Chief Operations Officer). The appointment decision was taken and approved by the advisory board responsible for product development and deployment. The CEO is responsible for strategic decision-making, communication, and management, and has the authority to hire and manage human resources decisions and financial resources required to achieve the project goals. The COO is responsible and has the authority to manage operations (discussed in the Operations section). The COO is directly responsible for sales and promotion operations and is accountable to the CEO and the rest of the project team. The COO’s main function is to raise and manage resources in ways that create maximum value for customers. The company is seeking to raise $2 million. This is the sum of money required to ensure the success of project completion, through setting the company, designing, developing, and testing the product. This sum also covers the promotional activities and administrative expenses incurred in the process of developing and implementing the project/ product. Project sponsors will be granted direct ownership rights for 50% of the future company shares. This also implies that sponsors will have voice in the company’s decision and direct opportunity to influence decisions and decision-making processes within the company. In exchange for funds, the company will offer strategic management rights and power to participate in the development and deployment of new products. Read More