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To start a clinical data management and clinical statistical analysis company, the first step is to decide which type of an organization you want to start. You have the following options:

1. Private Limited Company, including a One Person Company
2. LLC
3. Partnership
4. Sole Proprietorship

One this is decided, your next step should be to take steps for Data Management and protection. Since the pharmaceutical industry relies on the electronically captured data for the evaluation of medicines, a code called the Good Clinical Practices regulates all aspects of this function from designing, collecting, recording, maintaining all the clinical data. It also demands the use of validated systems to ensure accuracy, reliability, and consistency of data with the use of secure, computer-generated, time-stamped audit trails.

In India, Society for Clinical Data Management (SCDM) publishes the Good Clinical Data Management Practices (GCDMP) guidelines, which needs to be complied with. Clinical Data Interchange Standards Consortium (CDISC), a multidisciplinary non-profit organization, has also developed standards to support acquisition, exchange, submission, and archival of clinical research data and metadata within the CDM.

CDM Team: In a CDM company, the following team members are recommended:

1. Data Manager
2. Database Programmer/Designer
3. Medical Coder
4. Clinical Data Coordinator
5. Quality Control Associate
6. Data Entry Associate

Theoretically, the minimum educational requirement for a team member in CDM should be graduation in life science and knowledge of computer applications. Ideally, medical coders should be medical graduates. However, in the industry, paramedical graduates are also recruited as medical coders.

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