Q3 developed a PDA based clinical trial application, based on FDA regulations

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Company Profile

Client is the industry’s choice for medical institutions leveraging telecommunications technology based software services for managing biomedical data.

Business Situation

Client needed customized, proprietary software for collecting safety and efficacy data for new drugs and devices. Client required the software to be independent of the device used for recording and transmitting data, and allow the collected data to be accumulated on a centralized server, from where it could be accessed efficiently by authorized doctors and used for symptomatology. Client also wished to have complete control on the database as well.

Practical Situation

A doctor needs to monitor the body temperature of a patient at a certain specific time, everyday, for a specific period. The doctor requires this process to be automated so that the patient is reminded everyday to record and send his health information to the doctor using the PDA allotted to him.

Solution

Q3 set up a dedicated team consisting of a project manager, team leaders, and software developers to perform a detailed research on client requirements and unearth the complications or unsaid requirements.

Initial study of requirements document revealed that client needed software that facilitates Screening and Diagnostic trials, which are conducted to find better tests or procedures for diagnosing a particular disease or condition. Q3 understood that carefully conducted clinical trials are the safest and fastest way to find treatments and new ways to improve health and quality of life for people who have serious medical conditions.

Q3 also discovered that clinical trials are conducted according to a set protocol that specifies what types of patients may enter the trial, the length of trial, and outcomes of the trial. Client follows the protocol formed by the Food and Drug Administration (FDA) that sets the rules to ensure that people who undertake the trials are treated as safely as possible.

Q3 learnt that FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. Therefore, it was perceived that the software should support multiple languages and should lay special emphasis on human-computer interaction.

A detailed study on clinical trials disclosed that depending on the type of product and the stage of its development, doctors enroll healthy volunteers and patients into small pilot trials in the initial stage, which is followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. The number of patients is bound to increase as positive safety and efficacy data is gathered. Therefore, Q3 anticipated that the software should be scalable and extensible.

Q3 realized that it was important to build the clinical trial function in such a way so that it can meet the requirements of the doctors and patients. Each trial will consist of unique set of questionnaires that will be displayed or that will be accessible at regular intervals defined by the investigator/doctor or configuration parameters. A questionnaire will consist of questions that will be created using a flexible Computer Assisted Personal Interviewing System (CAPI). The patient will answer the questions in the questionnaire, and the answers will be sent to the centralized server, as desired.

Benefits

• Efficient and secure access to medical data for the condition being studied.
• Fully customized, scalable, and extensible software, along with source code.
• Extension of client’s development teams globally by taking advantage of Q3’s highly flexible Software Development Life Cycle (SDLC) methodology.
• Business model and culture at Q3 entails ownership of the product development process.