trials

7 Promises from God’s Word To Count On In Trials and Times of Darkness

In Unconditional Love: A True Love Story, Karen Sacchetti writes of a time in her life that began as a thrilling love connection.

BOCA RATON, Fla. (PRWEB) February 14, 2020
Karen Sacchetti’s book, Unconditional Love: A True Love Story ($14.99, paperback, 9781545645420; $7.99, e-book, 9781545645437), is available for purchase.
In Unconditional Love: A True Love Story, Karen Sacchetti writes of a time in her life that began as a thrilling love connection. Searching for love, Karen met Peter, a handsome charmer living in South Florida. After only four months of a long-distance relationship, Peter asked her to leave Rhode Island and move fourteen hundred miles to marry him. Soon after arriving in sunny Boca Raton, Karen realized that her dream was turning into a nightmare. Plagued by Peter’s alcoholism, womanizing, and incessant attention seeking, their fairy-tale romance quickly spun out of control, leaving Karen alone and disheartened. Her only confidant was Mike—Peter’s younger brother.
Although Mike proved to be Peter’s polar opposite by giving her the love and the loyalty she sought, Karen soon experienced new challenges, this time with the love of her life. Her journey provides the reader with a piercing view of the ravaging and destructive effects of Mike’s alcohol addiction and how their lives intertwined in a most unusual love story. Through all the adversity, Karen learned to press more deeply into God’s strength to see her through each day.
When none of her friends or family members saw the darkness surrounding her, God knew what she was facing daily. Karen not only unveils the details of the dark maze she was in, but also illuminates how God’s promises were fulfilled in her life. She received unconditional love from an all-loving Father, God. Could she extend the same love and grace to those who had hurt and betrayed her?
Karen Sacchetti is a creative dance educator, author, and creator of Adagio Stretch. She pursued her education at both Pennsylvania State University and Lesley University in Cambridge, Massachusetts, earning her Bachelor of Arts degree in drama, dance, and education from the latter in 1998. Karen established Adagio Stretch, http://www.karensacchetti.com. She implements the foundations of dance through a therapeutic approach to optimize brain and body functioning. In the early to mid-1990s, Karen acted and danced at the Riverside Theater in Boston.
Xulon Press, a division of Salem Media Group, is the world’s largest Christian self-publisher, with more than 12,000 titles published to date Unconditional Love: A True Love Story is available online through xulonpress.com/bookstore, amazon.com, and barnesandnoble.com.

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Building a Clinical Trials Website: How a Leading Sponsor Educates the Public, Engages Patients & Informs HCPs, Upcoming Webinar Hosted by Xtalks

Xtalks Life Science Webinars

The presentation includes a Q&A with the audience and will appeal to executives, directors, scientists, managers and others from pharma and biotech responsible for clinical trial transparency and access

TORONTO (PRWEB) January 14, 2020
Join the live session on Thursday, January 23, 2020 at 11am EST (4pm GMT) with guest speakers Robert Janiak, Head of Clinical Trial Transparency at Merck KGaA, Darmstadt, Germany, Jill McNair, Senior Director of Health Communications Services, at Center for Information & Study on Clinical Research Participation (CISCRP), and Naor Chazan, CMO at TrialScope.
In its ongoing commitment to patients, Merck KGaA, Darmstadt, Germany, which operates its healthcare business as EMD Serono in the US and Canada, has launched a dedicated clinical trials website using the TrialScope Engage™ platform.
To ensure that the site’s content meets the needs of patients and the public, Merck worked closely with the Center for Information and Study on Clinical Research Participation (CISCRP). The website features answers to commonly asked questions, videos and personal accounts to allay patients’ fears.
In this webinar, Robert Janiak from Merck will share why this became an organizational priority, its approach to the creation of the website and lessons learned along the way. Jill McNair from CISCRP will discuss how it obtained patient input and how that feedback guided content creation. Finally, Naor Chazan from TrialScope will explain how its technology — syncing clinical trial data to the website and generating robust search functionality — helps patients find and enroll in relevant trials, and keep participants informed of study updates and results.
The presentation includes a Q&A with the audience and will appeal to executives, directors, scientists, managers and others from pharma and biotech responsible for clinical trial transparency and access, including those in:
    Patient engagement
    Clinical trial recruitment
    IT
    Marketing/communications
    Regulatory/legal
    Research and development
    Clinical operations
    Project management
    Clinical trial planning and optimization
For more information or to register for this event, visit Building a Clinical Trials Website: How a Leading Sponsor Educates the Public, Engages Patients & Informs HCPs.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit http://xtalks.comFor information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/
Contact:Candice TangTel: +1 (416) 977-6555 ext 400Email: ctang@xtalks.com

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From The Avoca Group: New Report Introduces Benchmarks on Clinical Trials Vendor Qualification Process

PRINCETON, N.J. (PRWEB) January 09, 2020
A new report from Tufts Center for the Study of Drug Development establishes benchmarks for the vendor qualification process, a critical element of clinical trial set up and execution. According to its November/December Impact Report, the process volume and complexity of the vendor qualification process creates delays in initiation in 7% of clinical trials for biopharma sponsors and 14% of trials for Contract Research Organizations.
The analysis, conducted in collaboration with The Avoca Group, was based on data provided by 76 small, medium, and large pharmaceutical companies engaged in global drug development.
Among the key study findings summarized in the November/December Tufts CSDD Impact Report were the following:
In 2018, global spending for vendor qualification and requalification is estimated to be $375M, with 25,000 qualifications and requalifications conducted.
Vendor qualification assessment costs have large disparities and variances between companies; there is a need to standardize and optimize the process.
There is significant variation across the service provider domains evaluated; a standardized approach would greatly improve the efficiency of evaluations.
A high percentage of assessments, especially those conducted by larger companies, include customized areas of inquiry, which create challenges to streamlining and standardizing the processes involved.
There is no identifiable competitive advantage held by any company based on the approaches to vendor qualification examined; an industry-wide or third-party system might benefit every organization.
Cycle times for vendor qualification are lengthy and growing; the average total cycle time from an RFI request to a signed contract is 19.0 weeks for single-service providers and 26 weeks for multi-service providers.
“Evaluating external service providers is a time-consuming process that must meet the unique demands of each R&D program and account for, among other factors, regulatory compliance, risk management, cost efficiency, information technology expertise, operating, and financial controls and oversight,” said Ken Getz, principal investigator and deputy director of Tufts CSDD. “The volume and complexity of assessments needed to qualify and requalify potential vendors is increasing, and the benchmarks from this new study identify opportunities for drug developers to more effectively and efficiently manage this process.”
“The development of our new Diligent® Qualification Platform aligns with the vision we share with our partners to bring optimal efficiency and effectiveness to the quality and compliance elements of the clinical development process. With Diligent’s intuitive technology and suite of quality assurance assessment and auditing services, sponsors and CROs can rapidly identify, evaluate, and select clinical service providers,” said Patricia Leuchten, Founder and CEO of The Avoca Group. “Diligent accelerates the prequalification of clinical service providers by leveraging powerful analytical technology and industry-leading standards from the Avoca Quality Consortium®. Clients have seen significant reductions in vendor qualification cycle times, in most cases from weeks to days, using the Diligent Platform.”
Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
About The Avoca GroupThe Avoca Group is a life science consulting firm dedicated to improving quality and compliance in clinical trial execution. Since 2011, the Avoca Quality Consortium, a collaborative of over 100 pharma, biotech, CRO, and clinical service provider companies, has led the industry in developing practical solutions for improving quality and execution in clinical trials. Companies benefit from Avoca’s insightful research, deep subject matter expertise, industry-leading approaches, and technology. Avoca offers platforms and tailored solutions to help clinical research companies increase quality, ensure compliance, and improve efficiency so that medicines can reach patients faster.
About the Diligent Qualification PlatformThe Diligent Qualification Platform is a groundbreaking cloud-based technology platform as a service (PaaS) that streamlines and simplifies provider selection and qualification. Diligent makes identifying, evaluating, and selecting clinical trial providers more efficient and less expensive and meets today’s rigorous quality and compliance standards. Built on The Avoca Group’s extensive industry standards for clinical service provider qualification, Diligent meets the demands of today’s changing clinical trial landscape.

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From The Avoca Group: New Report Introduces Benchmarks on Clinical Trials Vendor Qualification Process

PRINCETON, N.J. (PRWEB) January 09, 2020
A new report from Tufts Center for the Study of Drug Development establishes benchmarks for the vendor qualification process, a critical element of clinical trial set up and execution. According to its November/December Impact Report, the process volume and complexity of the vendor qualification process creates delays in initiation in 7% of clinical trials for biopharma sponsors and 14% of trials for Contract Research Organizations.
The analysis, conducted in collaboration with The Avoca Group, was based on data provided by 76 small, medium, and large pharmaceutical companies engaged in global drug development.
Among the key study findings summarized in the November/December Tufts CSDD Impact Report were the following:
In 2018, global spending for vendor qualification and requalification is estimated to be $375M, with 25,000 qualifications and requalifications conducted.
Vendor qualification assessment costs have large disparities and variances between companies; there is a need to standardize and optimize the process.
There is significant variation across the service provider domains evaluated; a standardized approach would greatly improve the efficiency of evaluations.
A high percentage of assessments, especially those conducted by larger companies, include customized areas of inquiry, which create challenges to streamlining and standardizing the processes involved.
There is no identifiable competitive advantage held by any company based on the approaches to vendor qualification examined; an industry-wide or third-party system might benefit every organization.
Cycle times for vendor qualification are lengthy and growing; the average total cycle time from an RFI request to a signed contract is 19.0 weeks for single-service providers and 26 weeks for multi-service providers.
“Evaluating external service providers is a time-consuming process that must meet the unique demands of each R&D program and account for, among other factors, regulatory compliance, risk management, cost efficiency, information technology expertise, operating, and financial controls and oversight,” said Ken Getz, principal investigator and deputy director of Tufts CSDD. “The volume and complexity of assessments needed to qualify and requalify potential vendors is increasing, and the benchmarks from this new study identify opportunities for drug developers to more effectively and efficiently manage this process.”
“The development of our new Diligent® Qualification Platform aligns with the vision we share with our partners to bring optimal efficiency and effectiveness to the quality and compliance elements of the clinical development process. With Diligent’s intuitive technology and suite of quality assurance assessment and auditing services, sponsors and CROs can rapidly identify, evaluate, and select clinical service providers,” said Patricia Leuchten, Founder and CEO of The Avoca Group. “Diligent accelerates the prequalification of clinical service providers by leveraging powerful analytical technology and industry-leading standards from the Avoca Quality Consortium®. Clients have seen significant reductions in vendor qualification cycle times, in most cases from weeks to days, using the Diligent Platform.”
Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
About The Avoca GroupThe Avoca Group is a life science consulting firm dedicated to improving quality and compliance in clinical trial execution. Since 2011, the Avoca Quality Consortium, a collaborative of over 100 pharma, biotech, CRO, and clinical service provider companies, has led the industry in developing practical solutions for improving quality and execution in clinical trials. Companies benefit from Avoca’s insightful research, deep subject matter expertise, industry-leading approaches, and technology. Avoca offers platforms and tailored solutions to help clinical research companies increase quality, ensure compliance, and improve efficiency so that medicines can reach patients faster.
About the Diligent Qualification PlatformThe Diligent Qualification Platform is a groundbreaking cloud-based technology platform as a service (PaaS) that streamlines and simplifies provider selection and qualification. Diligent makes identifying, evaluating, and selecting clinical trial providers more efficient and less expensive and meets today’s rigorous quality and compliance standards. Built on The Avoca Group’s extensive industry standards for clinical service provider qualification, Diligent meets the demands of today’s changing clinical trial landscape.

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Graftless Bone Transplants Soon to Be Reality: ADAM Takes 3D Bones to Clinical Trials

A Connecticut-based bioprinting startup is piloting the use of ceramics and polymer in 3D-printed bone implants, able to be produced at commodity prices.
Press Release – updated: Dec 3, 2019 09:00 EST

GROTON, Conn., December 3, 2019 (Newswire.com) – On the shady campus of the BioCT accelerator in Groton, Connecticut, ADAM Project is preparing to take a solution to a decades-long health problem to clinical trials. The bone printing startup is currently prototyping two types of 3D-printed bones as safe, functional substitutes for traditional bone transplants. One type is made from ceramic, which merges with the patient’s tissue, the other from polymer. What’s unique about ADAM is that the bones they print can be constructed nearly as easily as any 3D-printed commodity.  
3D printing has been discussed as something of a magic bullet of organ and bone transplants for some time — and that’s just the problem. It has been nearly two decades since the first bioprinting efforts began, and yet in hospitals and clinics, the transplantation process remains relatively unchanged. Bioprinted bones are much simpler to engineer than tissues or organs, but finding the right materials has, nonetheless, been a major roadblock to mass adoption. 
Using inorganic but bioabsorbable materials, ADAM’s approach is essentially the same as industrial projects. After passing federal regulatory procedures, certified clinics would be able to print off transplantable bones in just one day on-site. In the U.S., where another name is added to the national transplant waiting list every 10 minutes, the impact of such technology would be a milestone in regenerative care. And while ADAM’s current focus is on bones, the R&D team is concurrently looking at potential uses for polymer in printing other tissues, such as heart valves and blood vessels. 
Dr. Cato Laurencin, distinguished orthopedic surgeon and director of the Center for Biomedical, Biological, Physical, and Engineering Sciences at the University of Connecticut, lends his expertise to the project as a scientific consultant. He says that cancer patients are one of the populations that will benefit from ADAM’s bones. 
“The skeleton is the most common site for metastases in patients suffering from cancer of breast, prostate, lung, thyroid, and kidney. When we talk about bone grafts, a big part of that is about intervening in cancer cases and offering patients a treatment that is effective and minimally invasive,” says Dr. Laurencin. “ADAM is using a material that is uniquely able to integrate with the recipient’s own tissue. That makes recovery in these cases possible, potentially more completely than is possible with current options.” 
ADAM is a member of BioCT and the BioFabUSA program of the Advanced Regeneration Manufacturing Institute (ARMI). The first human trials of ADAM bones will begin by the end of the year. 
Media/Investor Contact: 
Volodymyr Usov, CEO
Email: vu@adamproject.org
Denys Gurak, Chairman
Email: dg@adamproject.org
Source: ADAM Project

Graftless Bone Transplants Soon to Be Reality: ADAM Takes 3D Bones to Clinical Trials

A Connecticut-based bioprinting startup is piloting the use of ceramics and polymer in 3D-printed bone implants, able to be produced at commodity prices.
Press Release – updated: Dec 3, 2019 09:00 EST

GROTON, Conn., December 3, 2019 (Newswire.com) – On the shady campus of the BioCT accelerator in Groton, Connecticut, ADAM Project is preparing to take a solution to a decades-long health problem to clinical trials. The bone printing startup is currently prototyping two types of 3D-printed bones as safe, functional substitutes for traditional bone transplants. One type is made from ceramic, which merges with the patient’s tissue, the other from polymer. What’s unique about ADAM is that the bones they print can be constructed nearly as easily as any 3D-printed commodity.  
3D printing has been discussed as something of a magic bullet of organ and bone transplants for some time — and that’s just the problem. It has been nearly two decades since the first bioprinting efforts began, and yet in hospitals and clinics, the transplantation process remains relatively unchanged. Bioprinted bones are much simpler to engineer than tissues or organs, but finding the right materials has, nonetheless, been a major roadblock to mass adoption. 
Using inorganic but bioabsorbable materials, ADAM’s approach is essentially the same as industrial projects. After passing federal regulatory procedures, certified clinics would be able to print off transplantable bones in just one day on-site. In the U.S., where another name is added to the national transplant waiting list every 10 minutes, the impact of such technology would be a milestone in regenerative care. And while ADAM’s current focus is on bones, the R&D team is concurrently looking at potential uses for polymer in printing other tissues, such as heart valves and blood vessels. 
Dr. Cato Laurencin, distinguished orthopedic surgeon and director of the Center for Biomedical, Biological, Physical, and Engineering Sciences at the University of Connecticut, lends his expertise to the project as a scientific consultant. He says that cancer patients are one of the populations that will benefit from ADAM’s bones. 
“The skeleton is the most common site for metastases in patients suffering from cancer of breast, prostate, lung, thyroid, and kidney. When we talk about bone grafts, a big part of that is about intervening in cancer cases and offering patients a treatment that is effective and minimally invasive,” says Dr. Laurencin. “ADAM is using a material that is uniquely able to integrate with the recipient’s own tissue. That makes recovery in these cases possible, potentially more completely than is possible with current options.” 
ADAM is a member of BioCT and the BioFabUSA program of the Advanced Regeneration Manufacturing Institute (ARMI). The first human trials of ADAM bones will begin by the end of the year. 
Media/Investor Contact: 
Volodymyr Usov, CEO
Email: vu@adamproject.org
Denys Gurak, Chairman
Email: dg@adamproject.org
Source: ADAM Project