A prospective clinical research career!

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Contract research, a new business model, that arrived in India many years ago, has shaped itself to provide career opportunities to many individuals.

Several decades ago not a single contract research organization (CRO) was operating in our nation. With the onset of globalization, privatization and the gradual recognition of India at the international stage, a number of CRO’s and pharmaceutical companies began to set up their operations and explore India’s potential. It however took a great deal of time and effort to focus and establish clinical research organizations here. Continue reading

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Differences between Biologics and Pharmaceuticals

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As pharmaceutical companies are looking forward to expand their territories and expand their offerings in terms of products, the trend is moving towards Biologics. This brings us to our topic of discussion of what is the basic difference between a biologic and a conventional pharmaceutical product? Continue reading

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Digital Signatures in Clinical Trials (Electronic Signatures)

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A digital signature, also referred to as an electronic signature has been developed using the cryptographic techniques of verifying the originator. Using this technique, the identity of the person who uses a digital signature can be verified. The electronic system uses a complex set of rules and parameters to achieve this.

A digital signature is also known as an e-signature these days. It can be any electronic medium which certifies that the person who has signed the document electronically has read and understood the contents of the documents and is willing to comply with them. In simpler terms, it can be said that an electronic signature can be a synonym to a seal and will be considered legal and verified as the traditional hand written signature. Continue reading

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Clinical Data Management Steps and Processes

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The Clinical Data Management (CDM) process is like clinical trials, which required a fully planned and integrated scheme from the beginning to the end. The outcome of the process is considered first and the whole process of designing the system is made by considering the final deliverable in mind. The main purpose of an effective clinical data management process is to deliver a valid, error free and statistically relevant database. Continue reading

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