Struggle for actual data vs Melodrama Data

Clinical Trials- Advancement and Management

We all know what is the value of data, we all fights for our whole life for actual data based on that we make our most important decision. But what if someone tell any vague data and spread wrong message all over the nation.

Do you really think 11,500 Children dead and 45,000 Children paralyzed forever due to clinical trials? Can you believe this numbers?

What if someone tells this numbers on big platform like Movie, what impressions people will have about clinical trials? We requires Clinical Trials for medical advancement, don’t we need?

We are not against for upcoming Movie (Umeed) we requires authenticate data if someone is proposing “Based on True Events”. We truly believe presented data (11,500 children dead and 45,000 children paralyzed forever) are not correct.  Its good if someone spread awareness on unethical drug trials but it should not be fictional just…

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Virtual Clinical Trials: A complete Remote concept — smitshah21

Virtual Industry revenues will reach to $7.2 billion globally by the end of 2017 as in Greenlight Insight’s latest report. Anticipating modest growth in the short term, expects the Virtual industry to grow into a major global marketplace by 2021, reaching $74.8 billion in global revenues. Virtual industry remarkably uses cases including Tourism, Education, Sales […]

via Virtual Clinical Trials: A complete Remote concept — smitshah21

Big Challenges ahead/new Ideas to try- Need these five steps to Evaluate and Learn

Clinical Trials- Advancement and Management

Nobody knows everything:

Nobody knows everything, not even the CEO. Need to incorporate information from many sources. Instead, the information is distributed asymmetrically across the team and across the company. In this process, we have got to gather it and make sense of it and asking the experts is the best and fastest way to do that.

With luck, we chose our work because of bold vision. We want to deliver that vision to the world whether it is a message or service or an experience software or even a story or an idea. But bringing a vision to life is difficult. It I s always easy to get in endless emails, deadline that slip, meeting that burn up day, a long term projects based on questionable assumptions. It does not have to be that way.

If there is any idea, big challenge and not quite enough time and if…

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Risk Based Monitoring and it’s impact on Quality

RBM needs to redefine

Clinical Trials- Advancement and Management

RBM requires the ability for CRA to prioritize task and evaluate the performance of site which may involve auditing approach in monitoring.
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Auditors for identifying error and risk in clinical trials and they find the issues which missed by monitors. And that’s why auditors focus on identifying error with critical data and they are not pre occupied with less impactful activities like 100%SDV.

In five to 10 years, I believe that monitors will be trained to think and perform like auditors and relationship managers. Monitoring will still remain a necessary part of the industry, as important GCP concepts such as delegation of PI responsibilities and drug accountability cannot be performed remotely. However, monitors will be trained to evaluate the operations of a site, thus providing a far more reliable and valuable input into risk-based systems.

Training aspects are lacking with CRAs, and Impact on Clinical Trial Quality

Many years ago…

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