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ACRO Offers Unique Insights on Risk-Based Monitoring of Clinical Trials, and Calls for Adoption of RBM as a Best Practice

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WASHINGTON–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/clinicalresearch?src=hash” target=”_blank”gt;#clinicalresearchlt;/agt;–Following meetings with then-Commissioner Scott Gottlieb and senior
leadership from the Center
for Drug Evaluation and Research
on the role of CROs and technology
companies in designing and implementing risk-based monitoring (RBM) of
clinical trials, the Association
of Clinical Research Organizations (ACRO)
 this week submitted
extensive comments on recent FDA Guidance.

Increasing the use of innovative RBM technologies helps make clinical
trials safer, more efficient and higher quality. ACRO’s comments offer
unique insights into the recent expansion of RBM implementation and call
for further increasing the use of these oversight technologies.

Having surveyed its member companies, ACRO is pleased to report that
adoption of RBM tools is growing rapidly. In 2016, less than 20 percent
of new trial starts employed some form of RBM oversight. In 2018, a
majority of new trial starts were using RBM. Challenges to
implementation of RBM remain, including perceptions that traditional
oversight methods are lower risk and less subject to critical scrutiny
by U.S. and E.U. regulators.

ACRO’s comments note that the FDA could help increase RBM implementation
by articulating stronger and more straightforward support for risk-based
monitoring approaches, specifically describing RBM as a “best practice.”

In its comments, ACRO was pleased to include a graphic describing The
Risk-Based Monitoring Landscape
since 2016. “We look forward to
continuing to provide the FDA with unique insights from our member
companies,” said ACRO Executive Director, Doug Peddicord. “ACRO members
are innovators in the development of RBM technologies. We are pleased to
work with sponsors, research sites and the FDA to help ensure the safety
of trial participants and the quality of the data submitted for new
product approvals.”

About ACRO

The Association of Clinical Research Organizations (ACRO) represents
companies that provide a variety of specialized services that support
the development of new pharmaceuticals, biologics and medical devices.
Through its member companies, ACRO helps improve the quality, efficiency
and safety of biomedical research. ACRO member companies employ more
than 130,000 professionals worldwide and conduct or support the vast
majority of clinical trials.

Contacts

Matt Feldman
mfeldman@acrohealth.org

Trade Show News

Which CD is right for you? Continuous Deployment or Continuous Delivery? – Matt Beaney (AutoTrader UK) present the solution at TCE2019 Prague

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Software release expert will present a keynote session at PICANTE TECH Conference Europe 2019.

 

If you search online, you will find that continuous integration, continuous deployment, and continuous delivery are like vectors that have the same direction, but different magnitude. Their goal is the same: make our software development and release process faster and more robust.

The key difference between the three is in the scope of automation applied. What gets people who are new to the field confused is that they are not mutually exclusive, but include each other, like Russian dolls.

At PICANTE TECH Conference Europe (TCE2019), which will take place in Prague on the 3rd of September at Vienna House Andel’s Prague, you can hear more about the subject in a special keynote which will be presented by Matt Beaney, Service Transition at AutoTrader UK.

Matt has overseen Service Transition at AutoTrader UK for over 10 years, driving continual improvement of the release success rate from 85% to 99.8% and increasing the release rate from <600 to 15,000 per year. In Prague, he will tell you all about CD is right for you and your company.

REGISTER HERE to secure your seat!

PICANTE Tech Conference Europe is designed to bring both people and knowledge together and provides the excellent ecosystem of networking and learning opportunities without interruptions with emphasis on comfort and communication. After learning from genuine world-class experts and wayseers, meeting achievers shaping the B2B ecosystem, all attendees will get the chance to grab a drink and relax while networking at the evening social gathering.

REGISTER HERE or BROWSE THE AGENDA/PROGRAM!

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Cannabis

National Access Cannabis Corp. Provides Sales Update for Retail Cannabis Operations Since Federal Legalization

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National Access Cannabis Corp. (“NAC” or “the Company”) (TSXV: META), Canada’slargest cannabis retailer1, today provided investors with a corporate and retail sales update. The Company is successfully executing on its growth strategy and has achieved over $50 million in retail sales since legalization, with cumulative gross margin in excess of 31%. The Company is targeting to have 40 operating stores by the end of calendar 2019.

“NAC is rapidly growing its store count and revenue,” said Mark Goliger, CEO of NAC. “We have been granted 10 licenses in Alberta since the ending of the moratorium on May 31st, and we expect positive movement with our licence applications in British Columbia. We now have 30 stores open, with another 5 stores licensed and in development.  We expect continued revenue momentum as we roll out improved and streamlined store designs to enhance customer experience. With the recent filing of our final base shelf prospectus to provide us with flexible access to capital, we are confident in our ability to execute on our strategic growth initiatives to continue our leadership position in Canadian cannabis retail.”

The Company’s current portfolio of 35 licensed locations is split as follows:

  • 25 NewLeaf Cannabis™ stores in Alberta
  • 9 Meta Cannabis Supply Co.™ stores in Manitoba
  • 1 Meta Cannabis Supply Co.™ store in Saskatchewan

The newest retail location opened August 20, 2019:
NewLeaf Cannabis – Falconridge
55 Castleridge Blvd NE, Calgary

Previous announcements regarding NAC’s retail store expansion may be found through the following links:

August 8, 2019National Access Cannabis Corp. Continues Growth by Announcing Licence to Open a New Retail Cannabis Store in Alberta for a Total of 35 Licensed Retail Stores Across Canada and New Store Opening Update

July 30, 2019National Access Cannabis Corp. Continues Growth by Announcing Licences to Open Two New Retail Cannabis Stores in Alberta for a Total of 34 Licensed Retail Stores Across Canada

July 25, 2019National Access Cannabis Corp. Continues Growth by Announcing Licences to Open Two New Retail Cannabis Stores in Alberta for a Total of 32 Licensed Retail Stores Across Canada

July 3, 2019National Access Cannabis Corp. Continues Growth by Announcing Licences to Open Two New Retail Cannabis Stores in Alberta for a Total of 30 Licensed Retail Stores Across Canada

May 31, 2019National Access Cannabis Corp. Responds to the AGLC Lifting the Moratorium on Cannabis Retail Stores in Alberta

 

SOURCE National Access Cannabis Corp.

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The Use of Artificial Intelligence by Startups and SMEs panel discussion moderated by Dr. Robert Skalina (WH Partners) at TCE2019 Prague

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Leading law expert and tech compliance advisor to moderate the AI-related panel discussion at PICANTE TECH Conference Europe 2019.

 

The future is almost here and there are more and more talks about AI being a key part of our daily life. But, it seems we are not quite there yet as most of the services that are available are not the real independent AI which is feared by many doomsday preachers.

At PICANTE TECH Conference Europe (TCE2019), which will take place in Prague on the 3rd of September at Vienna House Andel’s Prague, we have put together an artificial intelligence-related panel discussion which will highlight some of the most recent topics that are discussed in the sphere and can benefit many in the upcoming period.

The panel discussion will be joined by Andjela Todorovic (Software Engineering Intern at Cubic Corporation), Jiří Třečák (CEO at Supernova), Aleksander Kijek (Chief Product Officer at Nethone) and last but not least, Vojtech Chloupek (Partner at Bird & Bird).

The futuristic thinking panel discussion will be moderated by Dr. Robert Skalina, Senior Advisor at WH Partners.

REGISTER HERE to secure your seat!

About Dr. Robert Skalina

Robert Skalina is a Czech Advocate as well as a Registered European Lawyer in Malta. He is based in Prague and works in Malta regularly.

He is financial services and corporate lawyer and provides advice to a wide range of investment managers, advisors and funds, including private equity and hedge funds. Robert also regularly advises clients in the gaming/gambling industries and has vast experience in the area of mergers and acquisitions and complex cross border transactions.

Robert has previously held the position of head of legal of a London based investment advisor active throughout the EMEA region. Prior to that, he served as legal counsel for the largest retail bank in the Czech Republic.

Robert graduated with an LLM cum laude from the London School of Economics. He holds a Master of Laws degree from the Charles University in Prague. He provides advice in English, Czech and Slovak.

PICANTE Tech Conference Europe is designed to bring both people and knowledge together and provides the excellent ecosystem of networking and learning opportunities without interruptions with emphasis on comfort and communication. After learning from genuine world-class experts and wayseers, meeting achievers shaping the B2B ecosystem, all attendees will get the chance to grab a drink and relax while networking at the evening social gathering.

REGISTER HERE or BROWSE THE AGENDA/PROGRAM!

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