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DCGI adds IVD devices for diagnosis of Covid-19, RNA & DNA extraction kits in Class C risk category under MDR-2017

AuroBlog - Aurous Healthcare Clinical Trials blog

The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.

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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

Among the various regulatory bodies providing oversight on clinical research, only the institutional biosafety committee (IBC) has a purview specific to research involving engineered genetic materials. The post Risk Assessment for use of Engineered Genetic Materials in Clinical Research appeared first on Advarra.

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Uptick in Clinical Trial Complexity: How Can You Achieve Your Clinical Trial Objectives Faster?

XTalks

“It’s important to make sure that with this increase in clinical trial complexity, we don’t make our trials overly burdensome to sites or patients,” says Markham. Keeping Trials on Track The preparation and analysis of samples within tight clinical trial timelines are crucial.

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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. The cfDNA that originates from tumors is called circulating tumor DNA (ctDNA). Also, exosomes are mostly being used for the detection of circulating RNA and microRNA. “An

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Spatial Genomics, Transcriptomics and Proteomics Solutions – An Amelioration of Tissue Analytics

Roots Analysis

As a result, industry and non-industry stakeholders, are on the lookout for advanced platforms that can simultaneously capture the arrangement of multiple biomolecules (DNA, RNA, proteins and others) with single-cell or subcellular resolution. 70+ spatial Genomics solutions are developed by industry and non-industry players.

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What Innovative Treatments For Metastatic Breast Cancer are being developed?

Find Me Cure

This Breast Cancer Awareness Month we’d like to talk about emerging areas in metastatic breast cancer treatment since clinical research has come so far in recent years. An enzyme involved in DNA repair can be the key to making chemotherapy more effective. Using the immune system against the cancer cells.

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Oligonucleotide Therapeutics and Delivery Conference

pharmaphorum

The two-day conference will bring you high-quality insights and industry connections on the latest clinical trial candidates and a platform for exchanging ideas for tackling the biggest challenge: DELIVERY.

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