Ready for a CRO That Values Performance Over Promises ...Medical Writing Safety / Pharmacovigilance...
Transcript of Ready for a CRO That Values Performance Over Promises ...Medical Writing Safety / Pharmacovigilance...
Ready for a CRO That Values Performance Over Promises?
CHALLENGE
At Clinipace, it’s personal.
With us, you get the “A” team.
We deliver a level of collaboration and control not possible in a traditional contract
research organization (CRO) environment. Our goal is to guide you successfully
through your clinical development program.
It’s personal for the life of your trial.
We take pride in building strong relationships and doing what is needed to
deliver solutions that move your drug candidate from bench to bedside.
With us, you make the decisions. Not only do we provide resources and
expertise when you need them, but we bring experience with us too — and
experience makes all the difference when you are facing tough questions.
We have applied our personal approach to more than 1,500 contract research
and 1,500 regulatory drug or medical device development projects worldwide
— carrying the flexibility to optimize your clinical development protocols, meet
aggressive timelines, execute regulatory strategies and complete high-quality
trials in a variety of therapeutic areas.
We are:• Your right-sized CRO
• Your trusted global clinical development partner
• Your expert regulatory development consultant
• Your broad technology infrastructure provider
ClinicalDevelopment
RegulatoryAffairs
Clinical Technology
Functional Services
At Clinipace, It’s Personal.
We Will PROVE IT.
Who We Are
We offer a helpful hand wherever you are.
With a team of 800 experts in more than 40 countries, we are the right size for
any study. We can help you conduct successful multinational studies by gaining
operational proficiencies and ensuring consistencies across local regulatory
requirements, treatment landscapes and varying standards of care.
Searching for a CRO With Extensive Access Across the Globe?
SOUTH AMERICA
• Argentina• Brazil• Peru
We Will BRING IT.
EUROPE
• Czech Republic• France• Germany• Israel• Italy• Poland
ASIA-PACIFIC
• Australia• China• Hong Kong• India• Japan
• Romania• Russia• Spain• Switzerland• Ukraine• United Kingdom
• Malaysia• Singapore• South Korea• Taiwan
NORTH AMERICA
• United States
Global Reach
Services
Save money, time and resources.
When your new product could change the future of medicine, you don’t have time for
delays. We are your strategic partner and committed to helping you find success during
your drug development journey.
Clinical DevelopmentGlobal, Personalized Clinical Research SolutionsWe Will BRING IT.
Phase I-III Clinical Research
At Clinipace, our goal is to help you get your new therapeutic to market
as quickly as possible while maintaining your milestones. We help you
thoroughly understand the safety, efficacy and side effects of your
investigational new product, for successful execution of your trial.
Phase IV Clinical Research
Our strategic development team has the expertise and technological
resources needed to help you execute your late-phase post-marketing
studies. We evaluate health-related quality of life and other patient-reported
outcomes for their impact on a patient population.
Expertise for Your Whole Trial.
We Will
Regulatory Affairs Knowledge for Navigating Challenging Regulatory PathwaysWe Will PROVIDE IT.
Moving drugs and biologics from the bench into the clinic and on to
market approval requires expansive expertise. From traditional small
molecules to advanced biologics, across the complete array of dosage
forms and a wide range of therapeutic areas, we will help you navigate
complex regulatory processes and advance your program into the clinic.
Clinical Development Phase I-IV Services
We provide a complete list of services for your next trial:
• Biostatistics and statistical programming
• Clinical data management
• Clinical operations and monitoring
• Clinical staffing
• Clinical technology
• Investigator recruitment and site selection
• Medical and scientific affairs
• Medical monitoring
• Medical writing
• Project management
• Quality risk management
• Regulatory affairs
• Safety/pharmacovigilance
Clinical AnalyticsFinding Quality Information in the DetailsWe Will DISCOVER IT.
The success of your trial relies heavily on your ability to answer questions
that help you improve patient outcomes and cut costs. Make the most out
of your clinical data — whether it’s quantitative, qualitative or transactional —
and gain access to a real-time snapshot of your trial status with our
clinical analytics services.
RegulatoryA�airs
Cardiology
Nephrologyand Urology
Gastroenterology Immunology InfectiousDiseases
Orthopaedic RespiratoryNutrition
THERAPEUTIC AREAS
Clinical Development
SERVICES
Clinical Analytics
Phase IVClinical Research
SOLUTIONS
Clinical DataManagement
ClinicalStang
Medical Writing
Safety /Pharmacovigilance
ProjectManagement
Quality RiskManagement
SiteSelection
Clinical Technology /Clarity Stack
FunctionalServices
Medical andScientific A�airs
ENTCNS
Phase I - IIIClinical Research
Oncology
Biostatistics andStatistical Programming
Experience That Drives Your Success.
We Will DELIVER IT.
Therapeutic Areas
Our Focus Areas:
Team up with qualified scientists and technicians.
We have completed more than 1,500 contract research and 1,500 regulatory drug or
medical device development projects across a number of therapeutic areas.
Complete Therapeutic Expertise:
GastroenterologyGastroenterology (GI) is a rich research environment, but it’s also competitive,
and changing at a rapid rate. As the landscape changes, we help you meet
the stringent requirements imposed by regulatory bodies on all phases of
drug development for the treatment of GI disorders.
Nephrology and UrologyNephrology and urology clinical trials include diverse and small patient
populations with complex diagnoses and comorbidities, which can bring
with them both high costs and patient recruitment shortfalls. We know there
are a myriad of factors to consider and have the ability to ensure efficient
recruitment and monitoring of your study’s progress and productivity.
Cardiology CNS
Orthopaedic Respiratory
OncologyAt Clinipace, we understand oncology study nuances: From the ever-changing
regulatory landscape to novel study designs and personalized treatment
options, we take care of your entire oncology program. And, we share your
passion for advancing cancer research and facing the challenges that bring
us closer to a cure.
RegulatoryA�airs
Cardiology
Nephrologyand Urology
Gastroenterology Immunology InfectiousDiseases
Orthopaedic RespiratoryNutrition
THERAPEUTIC AREAS
Clinical Development
SERVICES
Clinical Analytics
Phase IVClinical Research
SOLUTIONS
Clinical DataManagement
ClinicalStang
Medical Writing
Safety /Pharmacovigilance
ProjectManagement
Quality RiskManagement
SiteSelection
Clinical Technology /Clarity Stack
FunctionalServices
Medical andScientific A�airs
ENTCNS
Phase I - IIIClinical Research
Oncology
Biostatistics andStatistical Programming
RegulatoryA�airs
Cardiology
Nephrologyand Urology
Gastroenterology Immunology InfectiousDiseases
Orthopaedic RespiratoryNutrition
THERAPEUTIC AREAS
Clinical Development
SERVICES
Clinical Analytics
Phase IVClinical Research
SOLUTIONS
Clinical DataManagement
ClinicalStang
Medical Writing
Safety /Pharmacovigilance
ProjectManagement
Quality RiskManagement
SiteSelection
Clinical Technology /Clarity Stack
FunctionalServices
Medical andScientific A�airs
ENTCNS
Phase I - IIIClinical Research
Oncology
Biostatistics andStatistical Programming
RegulatoryA�airs
Cardiology
Nephrologyand Urology
Gastroenterology Immunology InfectiousDiseases
Orthopaedic RespiratoryNutrition
THERAPEUTIC AREAS
Clinical Development
SERVICES
Clinical Analytics
Phase IVClinical Research
SOLUTIONS
Clinical DataManagement
ClinicalStang
Medical Writing
Safety /Pharmacovigilance
ProjectManagement
Quality RiskManagement
SiteSelection
Clinical Technology /Clarity Stack
FunctionalServices
Medical andScientific A�airs
ENTCNS
Phase I - IIIClinical Research
Oncology
Biostatistics andStatistical Programming
RegulatoryA�airs
Cardiology
Nephrologyand Urology
Gastroenterology Immunology InfectiousDiseases
Orthopaedic RespiratoryNutrition
THERAPEUTIC AREAS
Clinical Development
SERVICES
Clinical Analytics
Phase IVClinical Research
SOLUTIONS
Clinical DataManagement
ClinicalStang
Medical Writing
Safety /Pharmacovigilance
ProjectManagement
Quality RiskManagement
SiteSelection
Clinical Technology /Clarity Stack
FunctionalServices
Medical andScientific A�airs
ENTCNS
Phase I - IIIClinical Research
Oncology
Biostatistics andStatistical Programming
Infectious Diseases and Vaccines
RegulatoryA�airs
Cardiology
Nephrologyand Urology
Gastroenterology Immunology InfectiousDiseases
Orthopaedic RespiratoryNutrition
THERAPEUTIC AREAS
Clinical Development
SERVICES
Clinical Analytics
Phase IVClinical Research
SOLUTIONS
Clinical DataManagement
ClinicalStang
Medical Writing
Safety /Pharmacovigilance
ProjectManagement
Quality RiskManagement
SiteSelection
Clinical Technology /Clarity Stack
FunctionalServices
Medical andScientific A�airs
ENTCNS
Phase I - IIIClinical Research
Oncology
Biostatistics andStatistical Programming
ENT
RegulatoryA�airs
Cardiology
Nephrologyand Urology
Gastroenterology Immunology InfectiousDiseases
Orthopaedic RespiratoryNutrition
THERAPEUTIC AREAS
Clinical Development
SERVICES
Clinical Analytics
Phase IVClinical Research
SOLUTIONS
Clinical DataManagement
ClinicalStang
Medical Writing
Safety /Pharmacovigilance
ProjectManagement
Quality RiskManagement
SiteSelection
Clinical Technology /Clarity Stack
FunctionalServices
Medical andScientific A�airs
ENTCNS
Phase I - IIIClinical Research
Oncology
Biostatistics andStatistical Programming
RegulatoryA�airs
Cardiology
Nephrologyand Urology
Gastroenterology Immunology InfectiousDiseases
Orthopaedic RespiratoryNutrition
THERAPEUTIC AREAS
Clinical Development
SERVICES
Clinical Analytics
Phase IVClinical Research
SOLUTIONS
Clinical DataManagement
ClinicalStang
Medical Writing
Safety /Pharmacovigilance
ProjectManagement
Quality RiskManagement
SiteSelection
Clinical Technology /Clarity Stack
FunctionalServices
Medical andScientific A�airs
ENTCNS
Phase I - IIIClinical Research
Oncology
Biostatistics andStatistical Programming
Immunology
RegulatoryA�airs
Cardiology
Nephrologyand Urology
Gastroenterology Immunology InfectiousDiseases
Orthopaedic RespiratoryNutrition
THERAPEUTIC AREAS
Clinical Development
SERVICES
Clinical Analytics
Phase IVClinical Research
SOLUTIONS
Clinical DataManagement
ClinicalStang
Medical Writing
Safety /Pharmacovigilance
ProjectManagement
Quality RiskManagement
SiteSelection
Clinical Technology /Clarity Stack
FunctionalServices
Medical andScientific A�airs
ENTCNS
Phase I - IIIClinical Research
Oncology
Biostatistics andStatistical Programming
RegulatoryA�airs
Cardiology
Nephrologyand Urology
Gastroenterology Immunology InfectiousDiseases
Orthopaedic RespiratoryNutrition
THERAPEUTIC AREAS
Clinical Development
SERVICES
Clinical Analytics
Phase IVClinical Research
SOLUTIONS
Clinical DataManagement
ClinicalStang
Medical Writing
Safety /Pharmacovigilance
ProjectManagement
Quality RiskManagement
SiteSelection
Clinical Technology /Clarity Stack
FunctionalServices
Medical andScientific A�airs
ENTCNS
Phase I - IIIClinical Research
Oncology
Biostatistics andStatistical Programming
Nutrition
RegulatoryA�airs
Cardiology
Nephrologyand Urology
Gastroenterology Immunology InfectiousDiseases
Orthopaedic RespiratoryNutrition
THERAPEUTIC AREAS
Clinical Development
SERVICES
Clinical Analytics
Phase IVClinical Research
SOLUTIONS
Clinical DataManagement
ClinicalStang
Medical Writing
Safety /Pharmacovigilance
ProjectManagement
Quality RiskManagement
SiteSelection
Clinical Technology /Clarity Stack
FunctionalServices
Medical andScientific A�airs
ENTCNS
Phase I - IIIClinical Research
Oncology
Biostatistics andStatistical Programming
RegulatoryA�airs
Cardiology
Nephrologyand Urology
Gastroenterology Immunology InfectiousDiseases
Orthopaedic RespiratoryNutrition
THERAPEUTIC AREAS
Clinical Development
SERVICES
Clinical Analytics
Phase IVClinical Research
SOLUTIONS
Clinical DataManagement
ClinicalStang
Medical Writing
Safety /Pharmacovigilance
ProjectManagement
Quality RiskManagement
SiteSelection
Clinical Technology /Clarity Stack
FunctionalServices
Medical andScientific A�airs
ENTCNS
Phase I - IIIClinical Research
Oncology
Biostatistics andStatistical Programming
Return on Your Investment.
We Will DELIVER IT.
Solutions
Clinical Technology Technology That Advances Your Trials We Will BUILD IT.
While all clinical research trials are using some level of eClinical technology,
the systems often operate in silos, making data collection, analysis and reporting
cumbersome. Clinipace’s Clarity Stack clinical technology will bring clarity to
your clinical trial through a continuous flow of integrated information and a
secure, holistic view of your clinical research trials.
Functional ServicesSupport for Your Core Capabilities We Will ACCOMPLISH IT.
We have the support and services you need, when you need them. Our team
takes your trial personally and we function as a direct extension of your
organization, dedicated to the success of your trial.
Services:
When you have clinical research and development questions, the answer is Clearly Clinipace.
Clarity Stack
Data Warehouse
Clarity Insight
Feasibility SSU eTMF CTMS
EDC
Safety: Oracle ArgusStatistical Analysis: SAS
BOTTOM ROW:Feasibility: Trial Interactive
CTMS: Bioclinica OnpointClarity Insights: Powered by Microsoft Power BI
Site Start Up: goBalto ActivateeTMF: Trial Interactive
TOP ROW:EDC: Medidata, Medrio
eCOA: ERTIRT: endpoint, Mediata
eCOA IRT Safety Stat Prog
Clarity FlowPOWERED BY ADAPTIVE CLINICAL®
• Biostatistics and statistical programming
• Clinical data management
• Clinical staffing solutions
• Medical and scientific affairs
• Medical writing
• Project management
• Quality risk management
• Safety/pharmacovigilance
• Site selection
© 2018 Clinipace Inc. | +1 919-224-8800 | www.clinipace.com