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Role of CRO’s in Medical Innovation and Drug DevelopmentCritical medical conditions such as new threats from chronic disea...
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Role of CRO’s in Medical Innovation and Drug Development

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Critical medical conditions such as new threats from chronic diseases and their debilitating conditions require quick responses and consistent attempts on a global level. Therefore, when the medical equipment and pharmaceutical biotechnology companies are in need to introduce efficient and effective drugs faster to the market, that is the time when they also need partners who are able to collaborate and assure them effortless development and service delivery.

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Role of CRO’s in Medical Innovation and Drug Development

  1. 1. Role of CRO’s in Medical Innovation and Drug DevelopmentCritical medical conditions such as new threats from chronic diseases and their debilitating conditions requirequick responses and consistent attempts on a global level. Therefore, when the medical equipment andpharmaceutical biotechnology companies are in need to introduce efficient and effective drugs faster to themarket, that is the time when they also need partners who are able to collaborate and assure them effortlessdevelopment and service delivery. The intrinsic advantages of a diverse and huge target pool for trials, legal andregulatory frameworks, global infrastructure, and a competent IT have assured Indian’s predominance as aptoutsourcing destination for medical causes all over the value chain. It is essential to mention here that the CRO’shave played an essential part of the process.Clinical Research Organization, also known as a CRO is a service organization that primarily assists thebiotechnology and pharmaceutical industries by outsourcing resource services, mostly domestic on the basis of acontract. The services offered by a CRO can range from preclinical research, biopharmaceutical development toclinical trials management. An eminent branch of study that deserves mention here is the Phase 1 Study that isusually backed up by the experiences of clinical trials. Renowned CRO’s in India provide state-of-the-artarchitecture that helps in conducting the Phase 1 Studies by volunteers. Some of them include the following:-  First-in-human  Single Ascending Dose Studies  Multiple Ascending Dose Studies  New Chemical Entity (NCE) Studies  Dose Escalating StudiesRegulatory services and QA too comprise an essential aspect of the service portfolio of popular CRO’s in India,having a dedicated group for audit compliance and regulatory services that is in turn supported by the expertise ofregulatory processes and efficient association with numerous regulatory agencies that assures efficiency inapproving medical trails and researches. The regulatory services provided comprise the following:-  Formulation of regulatory strategies  Compilation of the clinical trial application  Submission and follow-up of the application  Response to regulatory agency queries  Procurement of drug import licenses  Procurement of NOC for export of biological samples  Tracking of applications and approvals  Safety Reporting  Submission of Clinical Safety Report (CSR)  Renewal of Import LicenseThese apart, other innovative service offerings by CRO’s in India would include Quality Assurance, Central Lab,Project Management, Biometrics (consisting of Pharmacokinetic (PK) analysis, Statistical analysis and MedicalWriting), Bioanalytical studies and many more.

Critical medical conditions such as new threats from chronic diseases and their debilitating conditions require quick responses and consistent attempts on a global level. Therefore, when the medical equipment and pharmaceutical biotechnology companies are in need to introduce efficient and effective drugs faster to the market, that is the time when they also need partners who are able to collaborate and assure them effortless development and service delivery.

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