CTT is a clinical research organization that conducts Phase 1-4 clinical trials across many therapeutic areas. It provides value to sponsors through rapid start-up, successful subject recruitment strategies, an experienced team, and rapid data entry. The organization was founded in 2001 and has a 15,000 square foot facility and a network of over 50 physicians that allow it to safely and efficiently advance sponsors' research.
KPS Clinical Services (KPSCS) is set up by the RAHE Group, with an aim to become one of the India's leading research-based Contract Research Organization (CRO). Our commitment is to improve the quality of human life & to provide world class clinical research services to pharmaceutical, biotechnology, medical device companies, academic and government organizations.
We wish to focus on the prevailing issues in clinical research & give their solutions with a fresh and rational approach. In this endeavor, we have successfully established a team of highly qualified and experienced multi-disciplinary GCP trained personnel. The services provided by KPSCS are knowledge-driven and based on the understanding of the pharmacology and molecular basis of disease. We believe in providing quality services & we prioritize customer relationships.
A Presentation that promotes Evidence-Based Psychiatry and informed clinical decision making in the daily practice of Psychiatry. Prepared by Dr Yasser Amer and Dr Maged Elesely
KPS Clinical Services (KPSCS) is set up by the RAHE Group, with an aim to become one of the India's leading research-based Contract Research Organization (CRO). Our commitment is to improve the quality of human life & to provide world class clinical research services to pharmaceutical, biotechnology, medical device companies, academic and government organizations.
We wish to focus on the prevailing issues in clinical research & give their solutions with a fresh and rational approach. In this endeavor, we have successfully established a team of highly qualified and experienced multi-disciplinary GCP trained personnel. The services provided by KPSCS are knowledge-driven and based on the understanding of the pharmacology and molecular basis of disease. We believe in providing quality services & we prioritize customer relationships.
A Presentation that promotes Evidence-Based Psychiatry and informed clinical decision making in the daily practice of Psychiatry. Prepared by Dr Yasser Amer and Dr Maged Elesely
EVIDENCE-BASED CPGs FOR HEMATOLOGY - ONCOLOGY UNIT, KING SAUD UNIVERSITY HOPSITALS
Saudi Arabia, Riyadh
King Saud University Hospitals
CPGs Committee
Quality Management Dept
CPGs Program
By YASSER SAMI AMER
Purpose of the Call:
•Provide an overview of the MARQUIS toolkit components, informed by medication reconciliation best practices, designed to help hospitals improve the quality of their medication reconciliation processes
•Preview the preliminary results of the MARQUIS study in order to understand the effects of a mentored quality improvement intervention on medication reconciliation errors
•Discuss lessons learned from study sites that have implemented the MARQUIS program and how they might be applied to Canadian hospitals, including an exploration of barriers to implementation and how to overcome them
•Make the case for provinces, health systems, and hospitals to invest in medication reconciliation quality improvement efforts, and why physicians need to play a major role in these efforts.
Watch the webinar: http://bit.ly/1ji1voq
Purpose of the Call:
Change is challenging and getting staff clinicians and physicians to participate in quality improvement initiatives is often a struggle. Understanding the clinical perspective and developing effective change strategies can help.
By the end of this session participants will:
•understand why it is often difficult to engage with clinicians and physicians
•learn how to assess their change strategies for adoptability
•gain experience with the Highly Adoptable Improvement Model and Toolkit
Watch the webinar http://bit.ly/1A0mxOR
Overview of the progress of the KSUMC Clinical Practice Guidelines Adaptation and Implementation Program in the Department of Pediatrics which is the most active department in the program
Purpose of the call:
To learn about:
•successful strategies and approaches to engage patients and caregivers in MedRec,
•how teams effectively dialogue with patients and their caregivers on the benefits of having an accurate medication list, and
•the development of paper and electronic tools and resources created for patients and their caregivers to create and maintain their medication lists.
Watch the webinar http://bit.ly/1fnE61V
Let's Talk Research Annual Conference - 24th-25th September 2014 (Gail Woodburn)NHSNWRD
"Maximising the potential of the clinical research nurse workforce in order to promote research and innovation": Gail Woodburn's presentation from the conference.
Clinical Research Organization Services | Contract Research Company - PepgraPEPGRA Healthcare
Pepgra is a global contract research organization and drug development services company. It provides various phases of clinical research trials services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
India: +91 9884350006
United Kingdom: +44- 74248 10299
EVIDENCE-BASED CPGs FOR HEMATOLOGY - ONCOLOGY UNIT, KING SAUD UNIVERSITY HOPSITALS
Saudi Arabia, Riyadh
King Saud University Hospitals
CPGs Committee
Quality Management Dept
CPGs Program
By YASSER SAMI AMER
Purpose of the Call:
•Provide an overview of the MARQUIS toolkit components, informed by medication reconciliation best practices, designed to help hospitals improve the quality of their medication reconciliation processes
•Preview the preliminary results of the MARQUIS study in order to understand the effects of a mentored quality improvement intervention on medication reconciliation errors
•Discuss lessons learned from study sites that have implemented the MARQUIS program and how they might be applied to Canadian hospitals, including an exploration of barriers to implementation and how to overcome them
•Make the case for provinces, health systems, and hospitals to invest in medication reconciliation quality improvement efforts, and why physicians need to play a major role in these efforts.
Watch the webinar: http://bit.ly/1ji1voq
Purpose of the Call:
Change is challenging and getting staff clinicians and physicians to participate in quality improvement initiatives is often a struggle. Understanding the clinical perspective and developing effective change strategies can help.
By the end of this session participants will:
•understand why it is often difficult to engage with clinicians and physicians
•learn how to assess their change strategies for adoptability
•gain experience with the Highly Adoptable Improvement Model and Toolkit
Watch the webinar http://bit.ly/1A0mxOR
Overview of the progress of the KSUMC Clinical Practice Guidelines Adaptation and Implementation Program in the Department of Pediatrics which is the most active department in the program
Purpose of the call:
To learn about:
•successful strategies and approaches to engage patients and caregivers in MedRec,
•how teams effectively dialogue with patients and their caregivers on the benefits of having an accurate medication list, and
•the development of paper and electronic tools and resources created for patients and their caregivers to create and maintain their medication lists.
Watch the webinar http://bit.ly/1fnE61V
Let's Talk Research Annual Conference - 24th-25th September 2014 (Gail Woodburn)NHSNWRD
"Maximising the potential of the clinical research nurse workforce in order to promote research and innovation": Gail Woodburn's presentation from the conference.
Clinical Research Organization Services | Contract Research Company - PepgraPEPGRA Healthcare
Pepgra is a global contract research organization and drug development services company. It provides various phases of clinical research trials services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
India: +91 9884350006
United Kingdom: +44- 74248 10299
Elite Edition Europe's 5 Most Innovative CROs Pioneering Excellence.pdfinsightscare
In this exclusive edition of Insights Care, we present the Elite Edition, spotlighting Europe’s 5 Most Innovative Clinical Research Organizations (CROs). As we navigate the intricate landscape of healthcare advancements, we invite you to delve into the stories of these exemplary CROs shaping the future of clinical research.
Aldo Rolfo, National Clinical Development Manager, Genesis Cancer Care, Austr...GenesisCareUK
A program that seeks to redefine best practice across the drivers of the GenesisCare business (Quality, Access and Efficiency) in order to deliver on their vision of “Innovating Healthcare. Transforming Lives.”
ClinActis Pte Ltd is a Clinical Research Organization specialized in Asia Pacific, providing pharmaceutical, medical device, medical nutrition and biotech companies with state of the art clinical research services with an approach fully customized to the specificities of Asia Pacific.
Our regional coverage includes Singapore, Malaysia, Thailand, The Philippines, Vietnam, Indonesia, Taiwan, Hong Kong, Korea and Australia, as well as India through our strategic alliance with an Indian CRO.
Career In Clinical Research _ ProRelix Education (1).pdfTrishalaDeshmane1
Building a successful career in clinical research requires a strong foundation in science and medicine, specialized training in clinical research methodology, and a deep understanding of ethics and regulations
Service Overview
Site management services to CRO and SITE:
A) Pre initiation
Identification of Potential Sites
Faster Feasibility
Site set up, supplies and other infrastructure needs
Regulatory and IEC/ IRB communications
Rapid negotiation of CTA
Setting up Standard Operating Procedures (SOPs)
B) During Study Duration
Provide dedicated trained and experienced CRCs (Clinical research coordinators)
Patient recruitment & retention Support
Maintenance of essential documents
Source documentation as per ALCOA standards (Attributable, Legible, Contemporaneous, Original & Accurate
Regular IP (Investigational Product) accountability and storage
Completion of CRF’s within timelines
Faster query resolution
Reporting of AE, SAEs within timelines
Support Monitoring visits and Quality Assurance audit action items.
Patient visit Follow Up and compliance assistance
Preparation of site for monitoring and audits/ inspections
C) Post Close out
· Archiving of site results and documents
Site Identification
Faster Feasibility
Ready Sites
Customized Oncology Development Solutions: Clinical Trials Designed Around You®Covance
Oncology is one of the most research-intensive therapeutic areas, yet no two development programs are the same. No two trials are the same. Each one calls for a customized strategy and distinct trial management approach. Covance develops fit-for-purpose solutions Designed Around You® that enable more efficient clinical trials and focus on what is most valuable to your organization.
A joint presentation on Real People, Real Data at the 2016 International Forum on Quality and Safety in Healthcare in Gothenburg, Sweden. Presented by Leanne Wells of the Consumers Health Forum of Australia; Sam Vaillancourt of St. Michael’s Hospital, Toronto, Canada, and; Dr Paresh Dawda of the Australian National University.
Strand SmartLab - Enabling Precision Medicine at community HospitalsHarsha Rajasimha
Strand SmartLab is a complete soup to nuts solution that enables a community hospital to establish precision medicine testing services in-house. This enables the retention of revenues internally rather than loosing them to external third party laboratories. Genomics driven precision medicine for Cancer and other diseases require highly skilled people, lab equipment, processes, regulatory experts, bigdata software, databases and curation, medical geneticists to interpret the results in clinical settings and genetic counselors. Strand SmartLab brings all these to your institution in a pre-packaged solution.
To provide world class services to improve the quality of health care and reduce the efforts of our client in order to accelerate the overall process of drug development.
Evidence to Care: Mobilizing Childhood Disability Research into Practice
Dr. Shauna Kingsnorth
Evidence to Care Lead
Clinical Study Investigator
Assistant Professor (status), Department of Occupational Science
and Occupational Therapy, University of Toronto
Holland Bloorview Kids Rehabilitation Hospital
skingsnorth@hollandbloorview.ca
Presented at: Canadian Knowledge Mobilization Forum
Saskatoon, Saskatchewan June 9, 2014
2. CTT has the capability to conduct clinical research studies in a multitude of therapeutic areas, phases and design types. We work with major
pharmaceuticalanddevicesponsors,CROs,aswellassmallerbio-techcompaniestosuccessfullyandsafelyadvancetheirresearchanddevelopment
projects. CTT provides exceptional value to sponsors with rapid start-up capabilities, successful recruitment strategies, an experienced clinical
research team, rapid data entry and dedicated quality control.
Clinical Trials of Texas, Inc. (CTT) was founded in 2001 by
Kay Scroggins, RN, CCRC. Prior to forming CTT, Kay had over
16 years of clinical experience as a registered nurse and over 10 years of
clinical research experience, including serving as a CRA & CRA Manager
for a Contract Research Organization (CRO) and as Director of Research for a
doctor-owned research site. Kay’s vision to successfully conduct pharmaceutical
and device research studies with high integrity and exceptional quality is realized
today through the outstanding group of research professionals and investigators
affiliated with CTT.
CTT has a highly-equipped and versatile 15,000 sq. ft. facility capable of conducting Phase 1-4 studies in
a multitude of therapeutic areas. In addition to our Medical Director, Douglas Denham, DO, over 50
board certified physicians, who practice in the San Antonio area, work with CTT to conduct studies in their
respective medical specialties. This vast network of investigators has helped create one of the largest and
most capable research sites in the United States. The top priorities of CTT can be quickly understood by
simply reading our Mission & Vision Statement.
CTT Mission & Vision
To conduct clinical research protocols
safely, ethically, efficiently and accurately to
produce quality data for our sponsors.
h h h
To meet sponsor timelines, protocol
requirements and recruitment goals while
always keeping subject safety a top priority.
h h h
To treat research subjects with respect and
dignity for the great service and sacrifice
they make on behalf of the greater good of
our society, and to provide them with the
best possible customer service so that every
participant has a positive experience.
h h h
To maintain a professional and vibrant team
who respect each other, support each other
and promote positive thinking.
h h h
To achieve long-term success for the benefit
of each other and our families.
1
About CTT
2
A Top Quality Multispecialty
Research Organization
Departments
• Phase 1 Services
• Clinical Research Operations
(Phase 2-4)
• Medical Safety Director/Monitor
• Regulatory Compliance
• Subject Recruitment
• Clinical Laboratory
• Business Development
• Business Operations
• Quality Assurance
Physician Network
• Over50BoardCertifiedPhysicians
• Over20Specialties
• GCPCertifiedInvestigators
• InvolvedOversight
President, CEO
Kay Scroggins, RN, CCRC
Leading CTT with vision,
direction and innovation, Kay has
shaped Clinical Trials of Texas,
Inc. to become one of the most
capable clinical research sites in
the United States.
Highlights
• Access-Controlled15,000sq.ft.Facility
• Phase1InpatientFacilities
• BackupGenerators
• -80o
/-40o
/-20o
CFreezers
• 2-8o
CRefrigerators
• TemperatureDataLogging&PhoneAlert
SystemforAllMonitoredAreas
• RefrigeratedCentrifuge
• SynchronousAtomicClocks
• ProgrammableMedicalTreadmill
• CardiacStressSystem
• ECG/EEG/HolterCapabilities
• ProprietarySOPs
• Large&DiverseDatabaseofPotential
ResearchSubjects
• DEADrugCompliance
• X-Ray/MRI/CT/PET/Sonogram/DEXA
• NerveConductionVelocityTesting
• PulmonaryFunctionTesting
• Colonoscopy/EndoscopyCapabilities
• Limited-Access,Temperature-Controlled
DrugStorage
Medical Director
Douglas Denham, DO, CPI
As a Certified Clinical Research
Investigator, Dr. Denham provides
closemedicaloversightofclinicalstaff
and studies conducted at CTT. His
experienceandleadershiphelpensure
qualitydataandsubjectsafety.
Primary Specialties
• Vaccines
• Diabetes
• Women’sHealth
• Psychiatry-Adult/Adolescent/Child
• Neurology-Adult/Adolescent/Child
• GeneralPediatrics
• Dermatology
• Ophthalmology
• Gastroenterology
• Orthopedics
• SportsMedicine
• Oncology
• Otolaryngology(ENT)
• PainManagement
• SurgicalProcedures&Devices
• Neurostimulators
• VascularMedicine&Surgery
• Radiology
• InternalMedicine
• SleepTherapy
• Devices
• HealthyPopulations
3. 3
Phase II-IV
4
Inpatient Facilities
Our Phase 1 facility is connected to two
major hospitals and provides safe and
comfortable accommodations for study
subjects. Our facility has:
• Comfortable Lounge
• Computer Work Stations
• Wireless Internet
• Kitchen/Dining Areas
• Entertainment Options
ACLS Certified
• Investigators
• Nurses
• EMTs
• Research
Coordinators
Inpatient Study
Experience
• Pharmacokenetics/Pharmacodynamics
• First-in-Human
• Food Effect
• Cardiac Holter Monitoring
• Multiple Ascending Dose (MAD)
• Single Ascending Dose (SAD)
• Devices
• Healthy Populations
• Elderly Populations
• Pediatric Populations
• Sleep Apnea
Subject Safety
• Access-Controlled Facility
• 24-Hour Video Surveillance
• Emergency Pull-Cord System at each
bedside and in bathrooms
• Crash Cart
• AED
• ACLS Certified Investigator and Staff
• Phase 1 Emergency SOPs
Therapeutic Experience
Women’s Health:
Overactive Bladder, Contraception, Weight
Loss, Vaginal Atrophy, Osteoporosis, HPV,
Sexual Dysfunction, Fibrocystic Breast
Disease, Anemia, Heavy Uterine Bleeding,
Endometriosis, Uterine Fibroids, Hormone
Replacement Therapy, Premenstrual
Dysphoric Disorder
Psychiatry - Adult/Pediatric:
Depression, Bipolar I and II, Anxiety,
Sexual Dysfunction, Alzheimer’s Disease,
Adjunct Therapy, Obsessive Compulsive
Disorder, Tourette’s Disorder
Pain Management/Anesthesiology:
Opioid Induced Bowel Dysfunction,
Implanted Devices, Chronic Pain, Low
Back Pain, Knee Pain
Internal Medicine:
Hypertension, Dyslipidemia, Erectile
Dysfunction, Osteoarthritis, Influenza,
Congestive Heart Failure
Gastroenterology:
GERD, Ulcerative Colitis, Diverticulitis,
Gastric Ulcers, Irritable Bowel Syndrome
Vascular Medicine:
Peripheral Arterial Disease, Vascular
Surgery, Venous Leg Ulcers
Pediatrics:
Pediatric Vaccines, Asthma
Dermatology:
Rosacea,SurgicalWoundManagementSystems,
Cosmetics,LaserTreatments,Psoriasis
Neurology - Adult/Pediatric:
Migraines, Peripheral Neuropathic Pain, Post
Herpetic Neuralgia, Tourette’s Syndrome,
Stroke
Endocrinology:
Diabetes I and II, Obesity
Radiology:
PET, MRI, CT, Angiography, Ultrasound
Vaccines:
HPV, MMRV, RSV, Flu, Traveler’s Diarrhea,
Pneumococcal, Meningitis
Sleep Studies:
Sleep Apnea, Restless Leg Syndrome,
Narcolepsy, Insomnia
Device Studies:
Wound Dressing Systems, Implantable Devices
ENT:
OtitisMedia/Externa,Sinusitis,AllergicRhinitis
Pulmonary:
COPD, Asthma
Phase I
Capabilities
• Pharmaceutical Drug Studies
• Medical Devices
• Vaccines
• Surgical Procedures & Devices
• Wound Care Dressings
• Drug Delivery Systems
• Radiological Contrast Agents
• PK Studies
• In- & Out-Patient Hospital Studies
Secure Drug and Specimen Storage Cardiac Stress System and Programmable Treadmill
CTT conducts inpatient studies requiring overnight observation and procedures.
In-House Sleeping Quarters Handicap Accessible Showers
Phase 1 Lounge
Exam Room
4. 15,000 Sq. Ft. Facility Temperature Excursion Alert System
CTT Specializes in Vaccine Studies:
With years of experience, CTT has streamlined the processes required for executing large cohort, fast-enrolling
studies.Alsoimportant,CTThasanoutstandingrecordofsubjectretentionwithagreaterthan92%overallretention
rateinvaccinestudies.OurfacilityandstaffmakeCTToneofthemostcapablevaccinesitesinthecountry.
Rapid Start,
Quality Execution,
On-TimeDataDelivery
From study start to study end, CTT leads
the industry in meeting sponsor timelines
and delivering exceptional quality data. By
streamliningstudyexecutionthroughSOPs,
policiesandproceduresandaneffectiveteam
approach, CTT can work with accelerated
study timelines without compromising
quality. WithadedicatedQualityAssurance
Department, CTT achieves high quality
control of every data point that is delivered
to sponsors.
CTT focuses on
quality through
training.
Subject Recruitment
Today’s complicated protocols with increas-
ing subject eligibility criteria require more
creative recruiting resources and innovative
thinking than ever before. CTT’s dedicated
recruiting department leads the industry in
effective subject recruiting strategies. Re-
cruitment begins with a criteria-matching
search of CTT’s own research-specific data-
base of volunteers. Additionally, CTT’s net-
work of over 50 investigators helps identify
potential subjects from their own private pa-
tient databases. Innovative advertising cam-
paigns coupled with strategic mass-media
placement means that sponsors can save on
recruitment costs when compared to large
central ad agencies. Our presence and great
reputationinthelocalcommunityhelpbring
newvolunteersintoourfacilityeveryday.
Media Utilization:
• Television
• Radio
• Print
• Search Engine Marketing –
• Social Media –
5
Vaccine Trials
6
Quality Assurance
CTT’s QA/QC & Data Entry Department
performs a Quality Assurance and Quality
Control of study data prior to delivery to
sponsors. In addition to GCP/FDA/protocol
compliance, our skilled Quality Assurance
Team ensures that all data meet our P.A.C.T.*
System requirements. Dedicated data-entry
personnel input reviewed data into CRFs/
eCRFs ahead of sponsor timelines. Medical
oversight provided by our Medical Director
and board certified investigators help ensure
medical safety and data integrity.
*
OurP.A.C.T.System
ensures that data is
Punctual
Accurate
Complete
True
Clinical Team
Our team of research professionals includes:
• ACRP Certified Medical Director
• Board Certified Investigators
• Nurse Practitioners
• Registered Nurses
• Certified Clinical Research Coordinators
• IATA Certified Lab Technicians and
Study Coordinators
• Knowledgeable, Efficient Regulatory
Specialists
• Highly Skilled Data Entry Personnel
• GCP & Safety Trained Staff
• EMTs
• ACLS Certified Staff
Vaccine Study #1
• 50/50 male to female ratio required
by sponsor.
Vaccine Study #2
• Challenging population of healthy,
elderly subjects.
Vaccine Study #3
• Short enrollment period of
three weeks.
Vaccine Study #4
• Over-enrolled in just six weeks to
meet strict enrollment timelines.
Industry Leader
We have always met
enrollment goals,
even when time was
not on our side.