Tag Archives: CDM virtual team

Hashgraph: Electronic Data Capture Future?

Hashgraph technology, created by Leemon Baird, it is probably going to replace blockchain technology.

Since the introduction of bitcoin there have been many thousands of blockchain based crypto currencies created and there are more being created every single day so what’s different about hashgraph?

Well it isn’t a blockchain it’s totally different in fact the way it works is a real Mindbender and a bit difficult to explain.

Instead of a block in a blockchain hash graph calls their packages of information “events”. Your computer takes a transaction like a payment or anything else for that matter such an action in the eCRF form (e.g. SDV) you want to record and puts it in the event for transmitting information quickly hash graph uses a technology that has been the gold standards in computer science for decades. Its super fast and its called ‘gossip protocol’. Your computer randomly tells another computer in the network about the even you’ve created and that computer responds by telling your computer any events it heard about then that computer tells another computer about your event and the other events it heard about and the computer its talking to responds by telling all the events its knows about. Its absolutely the best most efficient way to spread information and it’s exponentially fast  And the best part, it also includes the information of the time it heard it and who it heard it from and the time they heard it and who they heard it from and so on and it is called ‘gossip about gossip’ and it lets everyone knows what everyone else knows and exactly when they knew it and just fractions of a second.

Another key feature is ‘virtual voting’. Even though an old technology, it was slow but with hash graph, there is no voting instead because everyone already knows what everyone else knows you can mathematically calculate with 100% certainty how they would vote and allows hash graph to come to consensus almost instantly so instead of recording things on a block and adding it to the block chain once every 10 minutes hash graph events are added to the system instantly the moment they are created so they don’t have 10 minutes worth of information in them. That means they are small and contain far less data so they use very little bandwidth and are much easier to transmit and uses a minuscule amount of power which makes it fast, fair and more secure than block chain.

All events are time-stamped the moment they are woven into the system so the record of whose event came first and whose came second is instant and there is no such thing as soft forking or unconfirmed events.

It can also replace huge portions of the internet that are currently run by centralized servers by replacing them with the shared computing power of all of our own computers, iPads and cell phones.

It looks like hash graph might have all the potentials  of fulfilling all the original hopes and dreams of a true Electronic Data Capture system (e.g. eCRF forms collected at site, ePRO/eCOA data directly from subjects, external or local lab or ECG data from any lab, eSAEs, Inform consents, and more). In other words, sites, sponsors, labs, regulatory and all vendors working seamless with each other.

Imagine an investigator or research site completing an ‘event’ (e.g. Enrolled or randomized) and the system automatically sent the payment to the site at the end of each event.

The power to decentralize and remove the middleman with the speed at which technology is evolving the future is looking bright.

One of the challenges of any new technology is how do you really explain to people how do you make a compelling case for what makes a technology so compelling and one of the things that is so compelling about this technology is throughput – the speed.

You are probably thinking but what about eSignatures? Or Informed Consents? or Regulations? There is another technology ‘smart contracts‘ that could lead to substantial improvements in compliance, cost-efficiency and accountability.

What is a  Smart contracts? are contracts whose terms are recorded in a computer language instead of legal language. Smart contracts can be automatically executed by a computing system, such as a suitable distributed ledger system. The potential benefits of smart contracts include low contracting, enforcement, and compliance costs; consequently it becomes economically viable to form contracts over numerous low-value transactions. The potential risks include a reliance on the computing system that executes the contract. [Distributed Ledger Technology: beyond block chain, UK Government Office for Science, 2006]

Smart contracts

Bitcoin technology uses a tremendous amount of energy to run the system and also it is scaled up it became slower and slower to where it was no longer a currency it was basically a speculative vehicle you could make some gains in purchasing power. A transaction with bitcoin technology can take 4 hours for confirmation.  With hashgraph, compared to Bitcoin, uses no power.

If Bitcoin were to replace the entire world monetary system and financial markets, it would use more power than the entire world produces. It’s completely unsustainable.

Hashgraph, smart contracts, distributed ledgers and similar technologies offer new ways to share information, reduce errors, and it is cost effective to all users. Perhaps a new Electronic Data Capture system for clinical research will emerge.

Source:

Hashgraph.com

The Crypto Revolution

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7 questions to ask yourself before you choose to set up your own Clinical Data Management department

The arguments to set-up your own Clinical Data Management department are various. You want to learn something new. You can do Clinical Data Management yourself because you could allocate resources for it. Conducting Clinical Data Management in-house could get you more in control of your clinical study data. Clinical Data Management done in-house could cost you less. You could perform Clinical Data Management better yourself. You want to spend your Clinical Data Management budget internally. You see a chance to make (more) money. You see a chance to (better) serve your Customers. You want to complete the gap in your clinical service(s).

Before you make the final decision you could ask yourself 7 questions:
1. For what type of studies should I want to conduct clinical data management myself? For all the studies I conduct? For the first clinical trials in the market application process? For phase III/IV clinical trials? Or for clinical studies conducted post registry?

2. Does a Clinical Data Management group fit in, and does it add value to my company’s core business? Is dedication to the Clinical Data Management performance part of my daily business targets?

3. Do I have enough studies, enough workload for Clinical Data Management to return investments? Is the cost-benefit ratio in my advantage?

4. Can I allocate enough resources, e.g. time, capacity, knowledge and money to the Clinical Data Management department to get clinical data quality from it?

5. Is this the right moment? Right now, should I invest in setting up a new department in my company? Is my company ready for the next step; an own Clinical Data Management group?

6. What are the benefits for my organization when we can conduct Clinical Data Management ourselves? What will it bring us?

7. What are the requirements for this Clinical Data Management department regarding the type of studies and the amount of studies. What are our user requirements for a Clinical Data Management system(s)? What is the capacity we need to handle that Clinical Data Management system and what information do we need?

The number one question in my experience; is a Clinical Data Management department a logical fit within your companies core dedication? Logical like ‘clinical research to get your products accepted for marketing’ or ‘providing clinical research services’. Dedicated Clinical Data Management can start returning investments.

Source:

This is an ezine of Maritza Witteveen of ProCDM. For Clinical Research Directors who struggle with clinical data management to get reliable, quality clinical study data successfully. Receive tips and the free e-book ‘Five strategies to get reliable, quality clinical data’ by subscribing via http://www.procdm.nl/pages/knowledgebase.asp.

Comments? Join us at {EDC Developer}

Anayansi Gamboa, MPM, an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.

Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)

As the 3 C’s of life states: Choices, Chances and Changes- you must make a choice to take a chance or your life will never change. I continually seek to implement means of improving processes to reduce cycle time and decrease work effort.

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