At Datafoundry, we feel that enabling trial setup and data capture in a simple, user-friendly manner is an achievable goal – even for complex trials. We have built DF mTrials AI EDC as the first solution in our Clinical Trials product line. It is a fully configurable product that doesn't require a Clinical DB Programming team to set up a study. A trial team can enrol subjects in a trial easily and they can begin the study without having to wait for weeks. Know More: https://datafoundry.ai/m-trials/

“Diversity.” It’s a word that is very commonly thrown around right now, not just in Pharma and healthcare but across all industries. No matter which sector you work in, diversity and inclusion should not be treated as mere buzzwords designed to help improve the perception of a company, but as must-haves. We live in a diverse world and our teams, clinical trial participants, customers, and key opinion leaders (KOLs) should reflect this. Read more: https://www.impetusdigital.com/2022/02/18/importance-of-diversity-in-pharma-and-clinical-trials/

Importance of Diversity in Pharma and Clinical Trials - Impetus Digital

Racial disparities are still commonplace in most clinical trials. It is known that factors such as ethnicity, sex, and age contribute to...

Samuel Searcy, Founder & CEO of CliniStart, sat down with me in this live Fireside Chat to explore trends, current gaps, and future predictions for clinical trials. Among many other things, we dived into tips for founding and leading a successful startup during a global pandemic, including his tips for building company culture virtually and why diversity and an open work environment are key.

The New Normal: Upcoming Trends in Clinical Trials - Impetus Digital

Samuel Searcy, Founder & CEO of CliniStart, explores trends, current gaps, and future predictions for clinical trials.

Natalie Yeadon, CEO & Co-Founder at Impetus Digital, provides insight into how COVID has changed clinical trials.

Episode 12 Not Going Back: How COVID Has Changed Clinical Trials - YouTube

Natalie Yeadon, CEO & Co-Founder at Impetus Digital, provides insight into how COVID has changed clinical trials.Schedule a meeting with Natalie Yeadon: http...

Here's a series of educational sessions designed to guide and develop skills in financial aspects of clinical research
https://www.linkedin.com/company/clinical-trial-financial-education/?viewAsMember=true

Design your protocol right first time. Learn how to optimise trial design from the outset by moving real world data insights upstream, join the webinar: https://lnkd.in/g_4X5tr

Learn from these experts:
· Juliette Chen, Director, Global Outcomes Research and Epidemiology, Takeda
· Joy Bhosai, Chief of Digital Health & Strategy, Duke University
· Christian Born Djurhuus, VP, Digital Transformation of Global Development, Novo Nordisk
· Robert DiCicco, Deputy Chief Health Officer, IBM Watson Health

Listen live on 14 May – 2pm London / 3pm Paris / 9am New York: https://lnkd.in/g_4X5tr

Currently seeking new position

Dear Community, Could you share your experience on  the therapeutic application of cannabinoids?I was reading related info:http://www.ccic.net/index.php?id=208,0,0,1,0,0Best,Yanet Vila

Clinical trials are no longer about hard clinical endpoints. Payers are increasingly demanding patient-centered outcomes as a prerequisite to approve access to new medicines. Once regarded as ‘nice to have’ measures, PROs are increasingly seen as essential tools.

eyeforpharma’s latest whitepaper provides an in-depth analysis of PROs across research, regulation and the real-world, and looks to a future where patient engagement is the start point for clinical development, not just an endpoint.

Read the full whitepaper here - http://bit.ly/2LcP6aR

Leaders from Sanofi, Novartis, Celgene, GSK, Takeda and others discuss:
• Why patient insights are the blueprint for effective PRO design
• How effective are PROs in securing patient access?
• PROs: The future of clinical trials?

Download your copy for free here - http://bit.ly/2LcP6aR

Enjoy!

Your sneak peek of the 16th Annual Cold Chain Global Forum agenda is here!

We wouldn’t want you to miss out on a week of networking and benchmarking against fellow clinical trial supply and pharma supply chain executives as we discuss obtaining meaningful results, getting drugs to market as fast as possible with little delays, & more.
View the Program: http://bit.ly/2L4OQXl

Clinical Focused Sessions Include:
-Roche Diagnostics on “How can we Successfully Transition from Clinical to Commercial Operations while Remaining Compliant of GMP’s and Regulatory Agencies?”
-“Regulatory Audits- How can we Ensure that all Regulatory Requirements are met through Good Manufacturing Practice (GMP) and Clinical Practice (GCP)?”
-“Maintaining Temperature Control Distribution with New Reduced Delivery Targets”

View the Program: http://bit.ly/2L4OQXl

Save Big Before May 31st!

We have Buy One, Get One Free Passes available until May 31st with promo code: 16GF_CLINICALRESEARCH. This offer is available to life science manufacturers, wholesalers and pharmacies and is off standard rates.

Email enquiry@iqpc.com to reserve your passes or visit the website: http://bit.ly/2L1KH6R

free consultations are provided by CRA School - telephone and email are available on their web site www.cra-school.com

There is no link to the organization mentioned. It would be nice if the article contained a bit more information about what kind of jobs are in this industry that are under-staffed.

Getting a license to practice in Canada or US as physician/veterinarian/dentist or pharmacist takes years and thousands of dollars, without guarantee of getting a job. On the other hand, the Regulatory Affairs jobs in the clinical trials industry DO NOT require neither a recognized diploma, nor a license to practice, are very well paid, and in a chronic and growing shortage of staff (25-27% or more). However, getting in is not easy without adequate support.

Access-Pharma Group celebrates 9 years of successful supporting the career reorientation of life science & health professionals into the clinical trials industry. You can get more information what is required for such roles and how to adapt your CV for them by emailing it for a free consultation to CRA School

I'm looking for new challenges/opportunities as a clinical Project Manager (freelancer/Consultant), preferably in early phase trials.

Cushing syndrome is a rare disease caused by the overproduction of cortisol, a hormone that regulates metabolism and our response to stress. Researchers at the Eunice Kennedy Shriver National Institute of Child Health & Human Development conduct research on Cushing syndrome, including clinical trials.

By Ed Miseta, Chief Editor, Clinical Leader
Follow Him On Twitter @EdClinical

Getting new treatments to patients is a long and costly endeavor. Most drugs take upward of eight years and billions of dollars to receive regulatory approval. One of the biggest problems sponsor companies face when trying to launch a Phase 3 trial is finding enough patients to take part in the study.

Everyone seems to be aware of the problem, but few have been able to offer a solution. The number of clinical trials is increasing, but it seems the number of patients available to participate in them is not. Research has found that 80 percent of trials are delayed due to recruitment issues, and many others will never get off the ground. The problem will only get worse as the number of trials continues to increase.

The underlying problems are well known to everyone in the industry. Many patients are not aware that clinical trials exist. Those patients who actually are aware of trials often have no idea where to find information on them or how to determine if they qualify for one. Physicians know their patients better than anyone, but most of them do not discuss trial options with them. Most physicians have also never served as an investigator on a trial, and those that do rarely return for a second one.

We Need Better Tools

I first learned about TrialReach back in August 2016. I interviewed Derek Rapp, president and CEO of JDRF, a global organization dedicated to funding research into type 1 diabetes. Rapp lamented the patient recruitment problem and how the industry simply did not have the right tools available to assist with recruitment. Something was needed to help patients find and enroll in trials, without the assistance of their physicians.

Rapp noted physicians are not aware of trials, are not trained on making referrals, and do not have the resources to participate in one. Others are actually fearful of losing patients that are referred to a trial. ClinicalTrials.gov, a government database containing details on current trials, can be difficult for patients to navigate and understand. But if patients are not aware of trials and physicians are not referring them, how do we solve the recruitment problem?

This is where TrialReach came into play. JDRF partnered with the technology provider to create Clinical Trials Connection, a tool patients could use to locate a clinical trial. By accessing the Clinical Trials Connection website and answering a few questions, patients are presented with a list of clinical trials for which they qualify. There are no ads. The graphics are simple and easy to understand. For patients, the process is simple and intuitive.

Shortly after launch, JDRF had well over 100 individuals per day accessing the site. On its best day, more than 4,000 patients performed a search for a trial. For patients and the JDRF, there is also no cost to use the tool.


Read more: http://bit.ly/2GfIKAs

Basel, February 14, 2018 -Novartis and the Bill & Melinda Gates Foundation have formed an alliance to advance development of Novartis' drug candidate KDU731 for the treatment of cryptosporidiosis. Diarrheal diseases are one of the leading causes of childhood mortality globally, resulting in approximately 525,000 deaths each year and cryptosporidiosis is the second leading cause of infectious diarrhea in children under 2 years of age[1]-[2]. "There is an urgent medical need for new and effective therapeutics for cryptosporidiosis, particularly in vulnerable populations" said Dr. Paul Kelly University of Zambia School of Medicine and Tropical Gastroenterology at Barts & The London.

KDU731 is a Cryptosporidium lipid kinase PI(4)K (phosphatidylinositol-4-OH kinase) inhibitor, which has been shown to effectively treat Cryptosporidium infection in preclinical models[3] and is currently undergoing safety studies prior to the initiation of clinical trials. Under the terms of the agreement, the Bill & Melinda Gates Foundation will provide $6.5 million to support the development of this drug candidate for the treatment of children by the Novartis Institute for Tropical Diseases (NITD).

"We are committed to the fight against cryptosporidiosis and other infectious and neglected tropical diseases and are proud to work closely with the Bill & Melinda Gates Foundation and other partners in this effort," said Thierry Diagana, Head of NITD. "Today`s global health issues cannot be solved by one organization alone. Private companies, governments, non-governmental organizations, academia, and other stakeholders need to work together to create sustainable solutions."

NITD is a Novartis research institute dedicated solely to the discovery and development of new medicines to treat malaria, cryptosporidiosis, and three major kinetoplastid diseases - human African trypanosomiasis (sleeping sickness), chagas disease and leishmaniasis.

Read more: http://bit.ly/2o7s8U4

Hi all!  Thanks for approving me to enter.  In addition to being open to new positions, I like to continue to grow my career and become certified where I can and attend conferences to learn more about Clinical Trial Agreements.  Does anyone have any other suggestions for Contracts professionals besides the MAGI conference?  Don't get my wrong, that conference is amazing, but I've already attended it in the past and was looking to broaden my horizons a bit.  Thank you!

Dear All - Medidata is hiring a number of new positions in Germany and Switzerland - and we're offering a referral bonus of   €3000 if you recommend someone who goes on to be hired. We're looking for Global Account Managers in Germany and Switzerland to manage our top 25 Global Pharma accounts.  Do you know someone who is a proven sales professional and has managed similar accounts in these regions, who wants to work for the market leader in Cloud Based Clinical trial software solutions? Message me directly for more information hspencer@mdsol.com and take a look at our openings https://www.mdsol.com/en/careers/sales-marketing

If you are looking for new people let me know - my team here are well equipped to help with the recruitment process state side and Canada based.

Pop an email to luke.blaney@rbwconsulting.com if you would like to know more.

Click to  review the job listing and apply today!   https://mapigroup.applicantpro.com/jobs/508666.html

https://www.eventbrite.co.uk/e/networking-drinks-medidata-solutions-in-germany-tickets-33461314693?ref=elink

Dear Colleagues, 

I am actively looking for opportunities in clinical supplies. I was recent Director of Clinical Supplies with a team of 14 people runn in h Global studies. I have experience in the EU and US and have introduced both novel and strategic solutions in the industry. I would appreciate opportunities for discussion as I explore the current marketplace. My area that I currently reside in is NJ.

Thanks in anticipation

David.

AMPEL BioSolutions is an
innovative, growing company in Charlottesville, Virginia poised to hire several
Senior CRAs to monitor clinical trials in the autoimmune disease SLE (systemic
lupus erythematosus).

 

Qualifications include a
Bachelor’s or Master’s Degree in the Scientific or Medical/Nursing fields, with
2+ years’ experience in clinical trials monitoring.  Essential qualities are a proven professional
track record of excellent communication, organization and motivation in
performing clinical monitoring tasks, with an exceptional eye for detail.  The successful applicant will be responsible,
energetic and detail-oriented.  Classes
in Medical Terminology, Regulatory Guidelines, Medical Records, Anatomy, Immunology,
Cell Biology or Pharmacology are helpful but not required.  AMPEL’s preferred applicants have experience in the
autoimmune therapeutic area.  Site visit
travel is around 30%. 

 

AMPEL’s Senior CRAs support
autoimmune clinical trials in the following ways: study start-up, feasibility,
site initiations, interim monitoring visits, data review and communications
through phone, skype, email, formal letters, and reports.  The AMPEL BioSolutions environment requires the ability to work
independently as well to be a productive part of a team.

 

This Senior CRA position provides
an upward opportunity for growth and breadth of experiences with a competitive package
of salary, 401K and medical/dental insurance.

 

Please send your cover letter, CV and
contact information for three references to:

 

Kate Vega at katevega@ampel.org

ATTN to:

Rebecca A. Bender, MS (UVA BA ’87)

Assoc. Dir. Clinical Operations

AMPEL BioSolutions

250 W. Main St, Suite 300

Charlottesville, VA 22902
Ph: 434-296-AMPL (2675)

www.ampelbiosolutions.com

StudyPal allows users to configure their own content. It is not an app to view all clinical trials, but it is an app that allows users to gather the silos from within their study. For example, rather than having to read the protocol for the incl/excl material or look for the study contact info, you can design it so users can access it easier. 

Advantages

1. Multiple protocols available at your finger tips.

2. You do not have to worry about whether the site has the latest version of the protocol or not.

3. Easily configurable and the changes are available right away.

4. You can set it up however you want. You can add Incl/Excl, Study video, Study flow or even study contacts for quick access.

5. Track who from the sites has been reviewing the updates.

6. Ensure the sites and investigators are receiving your push notifications and messages (you can track that too).

7. You can connect it with a Video for your products.

8. No hassle of printing papers and shipping.

9. Can easily access multiple protocols.

10. Multi-language ready.

11. Configurable via a web interface.

12. Compliant ready with full audit trail.

13. User authentication.