The document discusses the results of a 2014 survey on the use of data-driven approaches in clinical trials. It finds that while many respondents believe their use of such approaches has advanced in recent years, there is still significant room for improvement. Outsourcing relationships were seen as both promoting and potentially inhibiting their use, by increasing access to data and expertise but also sometimes creating challenges for change management and planning. Overall, the survey highlights opportunities to further apply analytical techniques to optimize clinical development processes and outcomes.
Effective risk management needs effective risk identification, assessment, planning, tracking and controlling in Clinical Trials. Considering the importance of risk management in efficient management of clinical trials, this webinar by DDismart will provide more insight on Clinical RBM.
The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials
Interactive Discussion Based on Data from Avoca’s 2013 Industry Research DIA Forum
June 24, 2013
Tackling the Challanges of Pharma ManufacturingJason Corder
By nature, pharmaceutical manufacturing operations are complex, inefficient, and consequently costly. Due to the inherent complexities, the cost of poor efficiency and its root causes are often not well understood by many manufacturers.
The clinical development data deluge is reaching critical mass for pharmaceuticals. Use of varied data for targeted outcomes remains difficult, despite studies that generate evidence of the risk-benefit profile of investigational products. New technologies are federating the ability to leverage analytic-ready data for innovations in clinical operations and clinical science. With the application of clinical data-as-a-service and meta-data core, centralized clinical data lakes have the power to improve data quality, evidence generation, and time-to-insights.
Karim Damji and Benzi Mathews presented this deck at the Clinical Trial Innovation Summit held in Boston on April 24-26.
Grounded in personal experience and expertise as a Trial Manager at Sponsors managing outsourced clinical trials, and as a CRO Trial Manager, this overview presentation builds on this background with the current landscape of managing trials for quality using an extended team.
This is one session in the 1-2 day course I teach on CRO-Clinical Vendor Management that includes Quality by Design and Quality Oversight of your vendors.
This course is provided to Sponsors and CROs who use sub-contractors for their client work.
4 Strategies to Influence Digital Health Approaches in Clinical Research StudiesJohn Reites
Drug Information Association (DIA) 2016 Conference presentation by John Reites on June 26, 2016. Session entitled; "Digital Health Debate" including this presentation on the four strategies to influence digital health approaches in clinical research studies.
All patients are different, and data collected during product development or Randomised Clinical Trials (RCT) does not always paint the full picture of everyday patients. RWE insights complement the manufacturing process and RCT findings, adding more value and providing real-world impact. While together data from the manufacturing process and RWD paint a fuller picture.
Due to the limitations of the study design, data from the manufacturing process and RCTs are inadequate for demonstrating an intervention’s long-term safety and effectiveness. Moreover, it is possible to compare multiple product or interventions in RWE.
If you had time for an open discussion with our MyRBQM® Academy instructors, what would you ask Johann, Jo, Linda, or Artem? In our monthly Ask the Expert webinars, we give you that chance. These webinars will focus on trending topics in the area of risk-based quality management (RBQM) - like remote and adaptive monitoring, centralized statistical monitoring, change management, predictive analytics... and more.
Besides a 20-minute Q&A session, our industry experts Jo Burmester and Dr Johann Proeve will dive into:
- How things might change while going forward post-COVID-19
- Statistical guidance for trials impacted by COVID-19
Learn more about MyRBQM Academy here: https://cyntegrity.com/myrbqm-academy/
Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.
We are driven by a passionfor transforming products into brands and patients into survivors. Navicor is a 100% healthcare-focused, full-service agency that understands the unique aspects of the oncology marketplace. We have extensive oncology launch experience and have partnerships with large and small pharma and biotech companies.
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
The Risk-Based Monitoring (RBM) discussion is moving away from one focused on changing monitoring methods and reducing source document verification (SDV) to 'intelligent monitoring.' Learn why here!
Niki Kutac, Director Product Management, delivered this presentation at the ACRP 2014 Conference where it was rated the #1 Session of the Event. Learn how to implement gamification to produce the desired end result.
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.Quality Management in clinical operations are Centralized Monitoring, Study Quality Metrics and CRO Oversight.
The FDA Guidance of a Risk-Based Approach to Monitoring as Viewed By CDMwww.datatrak.com
Historical Perspectives in CDM
Overview of the Draft Guidance
A Risked-Based Approach
Challenges to a Risk-Based Approach
Supporting a Risked-Based Approach
Risk based monitoring presentation into what Risk Based Monitoring (RBM) is all about. The value of getting it right, and the risks of getting it wrong. We look at the Triumph Research Intelligence (TRI) approach to RBM, and the TRI solution to RBM. An insight into the Future of Visual OPRA is given.
Transforming Pharmacovigilance Workflows with AI & Automation Perficient, Inc.
Medical information call centers have an opportunity to transform the way they capture, code, and analyze adverse events (AEs) and product quality complaints (PQCs) with artificial intelligence (AI) and automation.
The use of such innovative technology improves data quality and consistency, compliance, and operational efficiency. It helps reduce the frequency of your pharmacovigilance (PV) operations resources going home, saying, “I have more to do at the end of the day than I did when I started."
Our one-hour, on-demand webinar shows you how you can use AI and automation to turbo-charge your end-to-end PV system. Use cases and demonstrations will include:
Analyzing safety data
Auto-coding verbatim terms to official medical dictionary terms
Auto-creating an AE case in your database
Converting speech to text
J&J: Transforming Study Start-up in a Global Environment Veeva Systems
In this presentation, Lisa Rakebrand, Director Clinical R&D at J&J, discusses her team's vision to transform the way study start-up is conducted globally by leveraging Vault Study Startup to improve site collaboration, streamline site activation, and speed study start-up.
Effective risk management needs effective risk identification, assessment, planning, tracking and controlling in Clinical Trials. Considering the importance of risk management in efficient management of clinical trials, this webinar by DDismart will provide more insight on Clinical RBM.
The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials
Interactive Discussion Based on Data from Avoca’s 2013 Industry Research DIA Forum
June 24, 2013
Tackling the Challanges of Pharma ManufacturingJason Corder
By nature, pharmaceutical manufacturing operations are complex, inefficient, and consequently costly. Due to the inherent complexities, the cost of poor efficiency and its root causes are often not well understood by many manufacturers.
The clinical development data deluge is reaching critical mass for pharmaceuticals. Use of varied data for targeted outcomes remains difficult, despite studies that generate evidence of the risk-benefit profile of investigational products. New technologies are federating the ability to leverage analytic-ready data for innovations in clinical operations and clinical science. With the application of clinical data-as-a-service and meta-data core, centralized clinical data lakes have the power to improve data quality, evidence generation, and time-to-insights.
Karim Damji and Benzi Mathews presented this deck at the Clinical Trial Innovation Summit held in Boston on April 24-26.
Grounded in personal experience and expertise as a Trial Manager at Sponsors managing outsourced clinical trials, and as a CRO Trial Manager, this overview presentation builds on this background with the current landscape of managing trials for quality using an extended team.
This is one session in the 1-2 day course I teach on CRO-Clinical Vendor Management that includes Quality by Design and Quality Oversight of your vendors.
This course is provided to Sponsors and CROs who use sub-contractors for their client work.
4 Strategies to Influence Digital Health Approaches in Clinical Research StudiesJohn Reites
Drug Information Association (DIA) 2016 Conference presentation by John Reites on June 26, 2016. Session entitled; "Digital Health Debate" including this presentation on the four strategies to influence digital health approaches in clinical research studies.
All patients are different, and data collected during product development or Randomised Clinical Trials (RCT) does not always paint the full picture of everyday patients. RWE insights complement the manufacturing process and RCT findings, adding more value and providing real-world impact. While together data from the manufacturing process and RWD paint a fuller picture.
Due to the limitations of the study design, data from the manufacturing process and RCTs are inadequate for demonstrating an intervention’s long-term safety and effectiveness. Moreover, it is possible to compare multiple product or interventions in RWE.
If you had time for an open discussion with our MyRBQM® Academy instructors, what would you ask Johann, Jo, Linda, or Artem? In our monthly Ask the Expert webinars, we give you that chance. These webinars will focus on trending topics in the area of risk-based quality management (RBQM) - like remote and adaptive monitoring, centralized statistical monitoring, change management, predictive analytics... and more.
Besides a 20-minute Q&A session, our industry experts Jo Burmester and Dr Johann Proeve will dive into:
- How things might change while going forward post-COVID-19
- Statistical guidance for trials impacted by COVID-19
Learn more about MyRBQM Academy here: https://cyntegrity.com/myrbqm-academy/
Developing and maintaining strong relationships between the Sponsor and the selected CRO can make or break a clinical study. In this webinar, two experts with experience managing clinical programs from both a CRO and a Sponsor perspective provide tips and strategies for optimizing these relationships using real world examples.
We are driven by a passionfor transforming products into brands and patients into survivors. Navicor is a 100% healthcare-focused, full-service agency that understands the unique aspects of the oncology marketplace. We have extensive oncology launch experience and have partnerships with large and small pharma and biotech companies.
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
The Risk-Based Monitoring (RBM) discussion is moving away from one focused on changing monitoring methods and reducing source document verification (SDV) to 'intelligent monitoring.' Learn why here!
Niki Kutac, Director Product Management, delivered this presentation at the ACRP 2014 Conference where it was rated the #1 Session of the Event. Learn how to implement gamification to produce the desired end result.
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.Quality Management in clinical operations are Centralized Monitoring, Study Quality Metrics and CRO Oversight.
The FDA Guidance of a Risk-Based Approach to Monitoring as Viewed By CDMwww.datatrak.com
Historical Perspectives in CDM
Overview of the Draft Guidance
A Risked-Based Approach
Challenges to a Risk-Based Approach
Supporting a Risked-Based Approach
Risk based monitoring presentation into what Risk Based Monitoring (RBM) is all about. The value of getting it right, and the risks of getting it wrong. We look at the Triumph Research Intelligence (TRI) approach to RBM, and the TRI solution to RBM. An insight into the Future of Visual OPRA is given.
Transforming Pharmacovigilance Workflows with AI & Automation Perficient, Inc.
Medical information call centers have an opportunity to transform the way they capture, code, and analyze adverse events (AEs) and product quality complaints (PQCs) with artificial intelligence (AI) and automation.
The use of such innovative technology improves data quality and consistency, compliance, and operational efficiency. It helps reduce the frequency of your pharmacovigilance (PV) operations resources going home, saying, “I have more to do at the end of the day than I did when I started."
Our one-hour, on-demand webinar shows you how you can use AI and automation to turbo-charge your end-to-end PV system. Use cases and demonstrations will include:
Analyzing safety data
Auto-coding verbatim terms to official medical dictionary terms
Auto-creating an AE case in your database
Converting speech to text
J&J: Transforming Study Start-up in a Global Environment Veeva Systems
In this presentation, Lisa Rakebrand, Director Clinical R&D at J&J, discusses her team's vision to transform the way study start-up is conducted globally by leveraging Vault Study Startup to improve site collaboration, streamline site activation, and speed study start-up.
Leverage Big Data Analytics to Enhance Clinical Trials from Planning to Execu...Saama
Nikhil Gopinath, Senior Solutions Engineer for the Life Sciences at Saama, spoke at EyeforPharma's Clinical Trial Innovation Summit event in February 2017. These slides are from his "Leverage Big Data Analytics to Enhance Clinical Trials from Planning to Execution" presentation.
On April 18, 2016, The United States Supreme Court denied a petiti.docxvannagoforth
On April 18, 2016, The United States Supreme Court denied a petition for certiorari (refused to review the lower court’s ruling) in the case of Authors Guild v. Google, Inc., 804 F. 3d 202 - Court of Appeals, 2nd Circuit 2015.
Tell me what you would do if you were the Supreme Court.
That case let stand the ruling of the Court of Appeals, which can be found at the following website:
https://scholar.google.com/scholar_case?case=2220742578695593916&q=Authors+Guild+v.+Google+Inc&hl=en&as_sdt=4000006
Please write a 500-word summary of fair use as this court decision says it.
Running head: YOUR SHORTENED TITLE GOES HERE 1
SHORTENED TITLE GOES HERE (IN CAPS) 2
Plan
What is your plan for evaluation of the strategies using performance improvement data and tracers? What tracers will you use? Include necessary detail to deliver key points and requirements, such as specific data collection methods, timeframes for evaluation, and intended re-evaluation.
Tracer method is a unique technique used by the healthcare organizations, to obtain a real time picture of quality performance from point of entry to discharge. A key part of The Joint Commission’s on-site survey process is the tracer methodology (The Joint Commission, 2017).. Some traditional tracer tools can be used for quality and safety improvement. The focus of these tools is on ….. and the plan for the evaluation of this initiative for fall prevention will use tracers in the following manner….
OR
To evaluate the identified measure is the 30 day readmission rate for patients, data twill be racked by system tracers which will be completed monthly by the Assistant Director of Nursing.
Plan Evaluation
How effective and sustainable is your plan? In other words, evaluate the effectiveness and the ease of use, timeliness, and efficiency of your plan for the progress and success of your initiative.
The plan to prevent falls is effective and sustainable with the involvement and collaboration of all team members by implementing the following strategies… The initiative will be evaluated by the following methods, post implementation…….
OR
Every three months this data will be compiled and analyzed to determine what actions were effective and ineffective. The complete study will take place over a one year period with the desired result of an 15% or below hospital readmission rate.
Use of Tracers
Individual tracers make the most sense to utilize for this proposal because these tracers are designed to “trace” the care experiences that a patient had during hospitalization. For example: in case of fall prevention, these tracers help to track the patient’s experience regarding safety, satisfaction of personal needs, hygiene, compliance of staff during care….. System tracers can be utilized as well, for example….
OR
System tracers provide information by tracking where in an organizational process breakdowns occur or exist and are a valuable tool in identifying where changes needs to occur. ...
Transforming How Sponsors and CROs Interact with Clinical SitesPerficient, Inc.
Clinical trials are expensive. With the constraints of quality and compliance, the only way to reduce costs is to make trial operations more efficient. When study sponsors are able to automate workflows and efficiently exchange information, documents, queries, and supplies with their clinical sites, good things happen: confusion and errors are minimized, relationships with investigators and site personnel improve, and overhead costs plummet.
In this SlideShare, we discuss how organizations can use strategy, technology, and design to reduce clinical trial costs while improving quality and compliance.
Field Interactive MR’s consumer-panel, B2B-Panel, Healthcare-Panel and data collection capabilities in 98 countries helps our clients analyze the market, gain valuable insight and genuinely understand consumers.
For more information, please visit - http://fieldinteractive-mr.com/
Preliminary results from a survey on the use of metrics and evaluation strate...jehill3
Preliminary results from a survey on the use of metrics and evaluation strategies among mHealth projects
Patricia Mechael, Nadi Kaonga
Center for Global Health and Economic Development at the Earth Institute, Columbia University
CORE Group Spring Meeting, April 30, 2010
Cloud-Based Contact Center Study - Connect FirstConnect First
DMG’s worldwide survey of 169 enterprise, contact center, IT, operations, sales and marketing executives, managers and leaders in organizations of all sizes, found that 62.4% of respondents were already using cloud-based (also known as hosted) systems and applications in their contact center or customer service departments. There were close to 45 types of systems and applications used in contact centers, all of which are now available from vendors on-premise using the traditional licensing model, or in the cloud.
http://www.modernhealthcare.com/article/20140514/SPONSORED/305149926/webinar-turning-insight-into-action-analytics-effective-denials
Join us to learn how leaders at Middlesex Hospital turned insight into action by leveraging analytics to drive financial performance. This presentation will showcase how Middlesex streamlined its Denials Management process by using analytics to identify trends and opportunities for improvement, as well as for departmental managers to monitor operational aspects of the business.
By attending this webinar, you will learn:
- How post-denial write-off analytics provide immediate feedback for targeting payers, service type, denial type and/or high-dollar areas
- The impact near-real-time data can have on the feedback loops working with clinical departments
- The financial benefit of investing in a dedicated a Denials Management team
Similar to Partnerships in Clinical Trials 2014 (20)
PATRICIA LEUCHTEN WINS BRONZE STEVIE® AWARD IN 2013 STEVIE AWARDS FOR WOMEN I...The Avoca Group
Patricia Leuchten, founder and CEO of pharmaceutical consulting and survey research firm The Avoca Group, has been named the winner of a Bronze Stevie® Award in the ‘Maverick of the Year’ category. Leuchten accepted the award at the 10th annual Stevie Awards for Women in Business held in New York City.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
1. The State of Clinical
Outsourcing:
Impact of Outsourcing
Partnerships on Clinical Trial
Optimization
Data from the
2014 Avoca Industry Survey
Partnerships in Clinical Trials
2. 2
Denise Calaprice-Whitty, Ph.D. (Moderator)
Senior Consultant, The Avoca Group
Coleen Glessner
VP, Clinical Trial Process & Quality, Pfizer
Jamie MacDonald
CEO, Clinical Services, INC Research
Marisa Co
Vice President, BMS
Panel Members
Graeme Currie, Ph.D.
Vice President, Clinical Project Management and Operations,
Regeneron Pharmaceuticals
3. 3
2014 Avoca Industry Survey
Big Question:
How are “intelligent,” data-driven
approaches* being used in clinical
development today?
What factors promote their use, and
what factors inhibit it?
*For the purpose of this survey, an “intelligent,” data-driven approach was
defined as one that makes use of operational (e.g. performance) and/or
clinical data, along with appropriate analytical techniques, in order to
optimize aspects of clinical development such as protocol design, Investigator
selection, patient recruitment approaches, resource allocation (e.g. risk-based
monitoring), etc.
4. 4
Background: 2014 Avoca Industry Survey
Why now?
╸ “Big Data” concepts have become part of our daily experience
╸ Successful and highly visible use in other industries
o Moneyball
o Netflix
o Credit companies
o Facebook
╸ Clear opportunity in our industry
╸ Unprecedented availability and aggregation of digital information
╸ Even further promoted by high rates of outsourcing
╸ Continued time, cost, and quality pressures
╸ Easy to imagine areas of opportunity
5. 5
● Areas of opportunity, examples:
╸ overall protocol design, e.g. adaptive study designs, i.e. those adjusted
during the course of a study based on biomarker or clinical study data
gathered during the study
╸ procedural or eligibility aspects of protocols, e.g. examination of data
from previous studies to identify procedures/criteria associated with
high levels of protocol violations, cost, screen failures, etc. vs. value of
the data received
╸ selection of sites, regions, providers, or patient recruitment approaches,
e.g. use of performance databases to identify optimal selection for a
given function or study
╸ project management/oversight , e.g. data- or formula-based
identification of areas/periods of low/high risk, in order to allocate
oversight resources accordingly.
As with any change, however, companies must recognize and effectively
manage the forces that impact uptake and success.
Background: 2014 Avoca Industry Survey
6. 6
● Therefore, the 2014 Avoca Industry Survey explored the impact of
outsourcing relationships on this area.
● Specific research questions included:
╸ How frequently are “intelligent” approaches applied to each key area?
Among sponsors, how and why does this differ for in-house vs. outsourced
activities?
╸ How much advancement has been made over the last 2 years?
╸ How satisfactory are the results that are being seen?
╸ What forces have contributed to advancement, and what has impeded
it? What has been the impact of outsourcing partnerships?
╸ Experience with technology, training, and other implementation and
change management solutions
╸ Early engagement of partners in protocol and development planning:
Do you do it? Does it promote use of “intelligent” approaches? Does it
improve quality? How?
╸ Is the use of intelligent approaches impacted by the outsourcing model
employed (strategic vs. transactional, full-service vs. FSP)?
Background: 2014 Avoca Industry Survey
7. 7
● Sponsors: 127 Respondents
╸ Approximately 45% in top 20 in terms of revenue
o 67% Pharma
o 28% Biotech
o 3% Device
o 2% Combination/Other
● Clinical Service Providers: 105 Respondents
╸ 64% in top 20 in terms of revenue
o 67% CROs
o 33% Other/Niche
Respondents
2014 Avoca Industry Survey: Respondents
8. 8
Results: Application of Approaches
How frequently are “intelligent”
approaches applied?
How much advancement has
been made over the last 2 years?
How satisfactory have been the
results?
Questions 1, 2, and 3
9. 9
% of Respondents Reporting that Most of their Clinical Trials Use “Intelligent”
Approaches
(activities performed by the respondent’s company)
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Region selection
Site selection
Cost benchmarking/management
Provider selection
Project management/oversight
Protocol procedures/eligibility
Data collection tools
Overall protocol designs
Patient/volunteer recruitment
Monitoring (e.g. risk-based)
Sponsors (N=87) Providers (N=62)
Results: Application of Approaches
10. 10
% of Respondents Reporting at least “Moderate Advances” in the Use of
“Intelligent” Approaches over the Last 2 years
(activities performed by the respondent’s company)
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Site selection
Provider selection
Region selection
Data collection tools
Monitoring
Project management/oversight
Protocol procedures/eligibility
criteria
Overall protocol designs
Cost benchmarking/management
Sponsors (N=84) Providers (N=65)
Results: Rate of Advancement
11. 11
% of Respondents Reporting “Great Advances” in the Use of “Intelligent”
Approaches over the Last 2 years
(activities performed by the respondent’s company)
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Site selection
Monitoring
Data collection tools
Provider selection
Patient/volunteer recruitment
Overall protocol designs
Region selection
Project management/oversight
Specific protocol procedures or
eligibility criteria
Sponsors (N=84) Providers (N=65)
Results: Rate of Advancement
12. 12
For each of your in-house teams and your clinical service providers, please rate
your levels of satisfaction (1 to 5) with the application of "intelligent" (data-
driven) approaches on your projects, in each of the below areas.
Satisfaction with“Intelligent” Approaches
Sponsor ratings Clinical service
provider
self ratings In-house teams
Clinical service
providers
N= 65 54 54
Overall protocol designs (e.g. adaptive) 3.4 2.9 3.8
Specific protocol procedures or eligibility criteria 3.4 3.0 3.7
Site selection 3.3 3.1 3.9
Region selection 3.4 3.3 3.7
Provider selection 3.4 2.9 3.4
Patient/volunteer recruitment 3.2 3.1 3.6
Data collection tools (e.g. designs associated with
lowest query rates)
3.4 3.3 3.7
Monitoring (e.g. risk-based monitoring) 3.1 3.1 3.5
Other operational processes 3.2 3.1 3.4
Cost benchmarking/management 3.3 2.5 3.2
Project management/oversight 3.4 3.0 3.4
13. 13
Results: Rate of Advancement
Which aspects of progress have
depended (positively or negatively)
on outsourcing relationships,
and to what extent?
What types of change management
initiatives have made a positive
difference?
Questions 4 and 5
14. 14
Contributions of Service Providers: Sponsors
In your opinion, to what extent do your company's clinical service providers
either contribute to, or detract from, your company's use of "intelligent"
clinical development approaches?
19%
14%
21%
22%
7%
15%
4%
7%
3%
7%
50%
43%
37%
35%
37%
29%
36%
31%
26%
21%
26%
27%
35%
32%
36%
36%
41%
50%
40%
52%
46%
39%
3%
6%
7%
6%
13%
15%
11%
20%
20%
26%
26%
1%
1%
4%
1%
6%
2%
9%
0% 20% 40% 60% 80% 100%
Site selection
Region selection
Monitoring (e.g. risk-based monitoring)
Patient/volunteer recruitment
Project management/oversight
Data collection tools
Other operational processes
Provider selection
Specific protocol procedures or eligibility criteria
Overall protocol designs (e.g. adaptive)
Cost benchmarking/management
Essential contribution Significant contribution Little contribution
No contribution Negative contribution
N
70
69
73
72
67
68
56
55
66
57
57
15. 15
Do Partnerships Promote or Impede?
Sponsors Providers
Availability of data X
X
X
X
X
X
X
X
X
X
X
X
Availability of models and experience
Understanding of regulatory perspective
Technology
X
X
X
X
X
X
X
X
X
X
X
X
Contributors to Advancement
Principal Contributors to Advancement
16. 16
Do Partnerships Promote or Impede?
Sponsors Providers
External pressures
X
X
X
X
X
X
X
X
X
X
X
X
Resources
X
X
X
X
X
X
X
X
X
X
X
X
Contributors to Advancement
Principal Contributors to Advancement
17. 17
Do Partnerships Promote or Impede?
Sponsors Providers
Change management issues
X
X
X
X
X
X
X
X
X
X
X
X
Contributors to Advancement
Principal Contributors to Advancement
18. 18
Sponsor and Provider Data
Has your company implemented any specific change management initiatives to
help accelerate/improve the adoption of "intelligent" approaches to clinical trial
design and execution?
55%
63%
45%
37%
0% 20% 40% 60% 80% 100%
Sponsors
Clinical
Service
Providers
Yes No
N
69
52
19. 19
Sponsor and Service Provider Verbatim
● Increased resourcing in this area, creation of new roles (and/or service offerings) with
targets and accountability
● SOPs and process improvements, including joint sponsor-provider
● New technology
● Better data collection, review, analysis skills and tools
● Enhanced partnering/subcontracting initiatives
● Surveys to assess status and changes
● “Ambassador” programs
● Intensive and detailed training initiatives
● Broad employee engagement in designing changes
● Measurement of impact/ROI; case studies to show benefits
● Encouraging full risk assessment so that efforts are focused in the right place
Ø Importance of global initiatives supported by senior management
If "Yes", please briefly describe initiative and impact.
20. 20
Key Take-Aways
● Abundant opportunities exist for the application of “intelligent,” data-driven
approaches in clinical development.
● Many people believe that their companies have made substantial progress
in this area over the last two years.
● Outsourcing relationships may enhance uptake of such approaches,
principally by increasing access to aggregated data, expertise, and
experience.
● However, outsourcing relationships may also present challenges to uptake, in
the form of issues with change management and/or coordinated planning,
and in some cases, potential conflicts of interest.
Key Take-Aways
21. Thank you
Contact Avoca at:
(609) 252-9020
www.theavocagroup.com
info@theavocagroup.com
179 Nassau Street
Suite 3A
Princeton, NJ 08542