Our core competency, project management is underpinned by comprehensive and consistent processes, which conform to global regulatory requirements.
Regulatory authorities has a clinical trials of both non-registered statutory obligation to ensure that the drugs available in the country fulfils the necessary requirements for safety, quality and efficacy.
We provide a comprehensive guide to the basic principles, regulations and guidelines of ICH Good Clinical Practice, for conducting clinical trials and researches.
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Individual professionals or project teamsShort/long-termWide range of experiences and positions
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Adherence to ICH/GCP standardsLocal regulationsProtocol specific requirements
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Storing and maintaining the archival docs for not less than 15 years.
Small trials using younger donors and elderly recipients hint that mesenchymal stem cell transfers might reduce frailty.
-By Shawna Williams
The Good Pharma Scorecard finds some big pharmaceutical companies are meeting legal standards for disclosing results—but many studies still go unreported.
-By Diana Kwon
A team of Stanford University researchers say that administering young people’s blood plasma to Alzheimer’s patients could improve cognitive function, but the results have been criticized.
-By Catherine Offord
SCENFIC CRO providing quality full service clinical trial support to local and global pharma, biotech and medical device companies with clinical trial services
- Santhosh Kumar, CEO
- Lallith Sai, MD
7/3-1,8TH CROSS, KP AGRAHARA,MAGADI ROAD,BENGALURU(BANGALORE) URBAN,KARANATAKA,560023.
+91-(080)-9655 545 640
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From start-up to completion, performance is monitored and measured against contractual timelines and project costs are tracked to ensure adherence to agreed budgets.In an increasingly challenging environment, we have the experience and knowledge to find, recruit, and retain patients in clinical trials. We successfully deliver access to appropriate sites and patients, developing strategies that will minimise the risks inherent in patient recruitment.
Regulatory authorities are responsible to implement a regulatory system where in all clinical trials to be conducted in the country have to register with them. Regulatory authorities will have the overall responsibility to promote , ensure and monitor compliance by approved ethics committees in a country with relevant legislation, regulations and guidelines including guidelines for Good Practice in the Conduct of Clinical Trials in HumanParticipants in the country.Regulatory authorities are responsible for effectively reviewing all the documents (containing both clinical and non clinical data) before giving permission for the marketing of a new drug in any country to ensure the efficacy and safety of the drug in humans.
The ICH-GCP or the International Council on Harmonisation Good Clinical Practice guidelines are an international quality standard for the planning, execution, supervision, documentation and auditing of studies involving human subjects.This course is based on the international E6 ICH Good Clinical Practice regulations and is a complete training solution for all individuals that need to acquire GCP knowledge.