Clinical Trials Market Assessment and Forecast Report by Future Market Insights
Documents required for performing clinical trials are investigator’s brochure (IB) which include current and relevant scientific information about the investigational product, United States Food and Drug (FDA) form 1572, protocol and amendments, inform consent, other written information for participants, recruitment advertisement, financial disclosure form (FDF), master clinical trial agreement (MCTA), institutional review board (IRB) approval, medical licensure, training records, laboratory accreditation, visit monitor reports, miscellaneous document, signature sheet and documentation of investigational drug destruction. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together regulatory authorities of Europe, the United States, Japan and experts from pharmaceutical industry to frame and regulate the technical and scientific aspects of pharmaceutical product registration. The Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) states rules and standard guidelines for clinical trials. ICH guidelines are followed as law by several countries in the world.
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Clinical trials are conducted in four phases namely, Phase I, II, III and IV. Phase I is conducted for safety, phase II is conducted for efficacy, phase III is conducted for final confirmation of safety and efficacy and phase IV is conducted for post sales studies. Risk to participants involved in clinical trials decreases from phase I to phase VI. Number of participants increases from phase I to phase IV resulting in increasing cost of trials. Based on the phases of clinical trials, global clinical trials market is segmented as follows:
Based on indication, global clinical trials market is classified as follows:
Central nervous system (CNS)
Cardio vascular system (CVS) diseases
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Being relatively costly process, in order to reduce economic burden on company and shift focus on core business activities, many companies outsource their clinical trial activities to contract research organizations (CROs). Contract research organizations provide services such as clinical trial management, clinical research and preclinical research. Factors such as advancement in technology and increasing demand of innovative solutions in healthcare industry are driving the market of global clinical trials towards growth. On the other hand, factors such as high cost and stringent regulations are restraining the growth of clinical trials market globally. Geographically, the global clinical trials market is segmented into North America, Europe, Asia-Pacific and Rest of the World.
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