trials

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

Tommy L. Romans’s newly released “Experiencing God's Grace in Your Trials” is a heartwarming testament to God’s sublime love that beckons humankind to salvation

MEADVILLE, Pa. (PRWEB) December 02, 2019
“Experiencing God’s Grace in Your Trials: Being Victorious”: an enriching proclamation of God’s benevolence in life as proved by his guidance over humanity against evil. “Experiencing God’s Grace in Your Trials: Being Victorious” is the creation of published author Tommy L. Romans, an ordained minister, Sunday school teacher, and inspirational writer.
Romans shares, “Have you ever wondered what life was like in the Garden of Eden before Adam and Eve sinned? What did it really feel like to live in such a wonderful and charming place of perfect peace and harmony? It was surely paradise for our first parents. There was not a trace of evil, not a hint of anything bad that would hurt or mar until the great tempter showed up. The Bible calls him the devil— our archenemy and master of deceit whom Jesus describes as a thief who comes to steal, kill, and destroy. Satan appeared to Eve as a beguiling, harmless serpent but since then has taken many subtle and artful forms.
“As you prayerfully read from these inspired pages, the author takes you through the Bible on a thrilling adventure that will hold you in suspense as you watch the battle between the forces of good and evil take place. The stage is being set, and the final battle of the ages is now beginning to unfold and will soon take place between God and Satan. It is a battle for the souls of man. You will see Satan’s many cunning tactics and come to understand the devices he uses to lead people away from a loving God and cause them to fall and fail.
“Are you going through a trial or being tempted? Is there something you are up against and battling? Are you or someone you know suffering some hardship and have fallen victim to Satan and failed? Don’t give up! You will discover in this book God’s redeeming grace. You will behold God’s salvation and love for His children like you have never witnessed. Through the pages, you will see Him reaching to the lost and confused, to the troubled and hurting. You will discover God’s saving and delivering power is much greater than Satan. You will find He’s greater than any and all failure and sin, no matter how big or bad. You will behold His forgiveness and cleansing and see lives transformed and healed. When you finish reading this God-inspired work, you will be able to recognize Satan’s many deceiving ways. You will be able to see right through every temptation and lie of your enemy and avoid hurt and disaster in your life, your home, and church. This book will teach you how to put on the whole armor of God and be an overcomer. You will understand God’s guidance and learn His voice that will keep you safe. In the midst of your trials, you will learn to trust God, hold on to faith, and come out victorious. Dear reader, there is hope—God is still making winners! May God bless you as you start this journey!”
Published by Christian Faith Publishing, Tommy L. Romans’s new book reminds readers of the battle of good and evil and how God’s compassion brings about redemption to those who uphold his teachings and remain faithful to him.
This book purports as a stepping-stone to a deeper understanding of God and the importance of trusting his will in one’s life.
View the synopsis of “Experiencing God’s Grace in Your Trials: Being Victorious” on YouTube.
Consumers can purchase “Experiencing God’s Grace in Your Trials: Being Victorious” at traditional brick-and-mortar bookstores or online at Amazon.com, Apple iTunes store, or Barnes and Noble.
For additional information or inquiries about “Experiencing God’s Grace in Your Trials: Being Victorious,” contact the Christian Faith Publishing media department at 866-554-0919.

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