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




THERAPEUTIC AREAS


SERVICES

Clinical Analytics


SOLUTIONS


ClinicalStang

Medical Writing


ProjectManagement


SiteSelection


FunctionalServices


ENTCNS


Oncology


RegulatoryA�airs

Cardiology




THERAPEUTIC AREAS


SERVICES

Clinical Analytics


SOLUTIONS


ClinicalStang

Medical Writing


ProjectManagement


SiteSelection


FunctionalServices


ENTCNS


Oncology


RegulatoryA�airs

Cardiology




THERAPEUTIC AREAS


SERVICES

Clinical Analytics


SOLUTIONS


ClinicalStang

Medical Writing


ProjectManagement


SiteSelection


FunctionalServices


ENTCNS


Oncology


RegulatoryA�airs

Cardiology




THERAPEUTIC AREAS


SERVICES

Clinical Analytics


SOLUTIONS


ClinicalStang

Medical Writing


ProjectManagement


SiteSelection


FunctionalServices


ENTCNS


Oncology


Infectious Diseases and Vaccines

RegulatoryA�airs

Cardiology




THERAPEUTIC AREAS


SERVICES

Clinical Analytics


SOLUTIONS


ClinicalStang

Medical Writing


ProjectManagement


SiteSelection


FunctionalServices


ENTCNS


Oncology


ENT

RegulatoryA�airs

Cardiology




THERAPEUTIC AREAS


SERVICES

Clinical Analytics


SOLUTIONS


ClinicalStang

Medical Writing


ProjectManagement


SiteSelection


FunctionalServices


ENTCNS


Oncology


RegulatoryA�airs

Cardiology




THERAPEUTIC AREAS


SERVICES

Clinical Analytics


SOLUTIONS


ClinicalStang

Medical Writing


ProjectManagement


SiteSelection


FunctionalServices


ENTCNS


Oncology


Immunology

RegulatoryA�airs

Cardiology




THERAPEUTIC AREAS


SERVICES

Clinical Analytics


SOLUTIONS


ClinicalStang

Medical Writing


ProjectManagement


SiteSelection


FunctionalServices


ENTCNS


Oncology


RegulatoryA�airs

Cardiology




THERAPEUTIC AREAS


SERVICES

Clinical Analytics


SOLUTIONS


ClinicalStang

Medical Writing


ProjectManagement


SiteSelection


FunctionalServices


ENTCNS


Oncology


Nutrition

RegulatoryA�airs

Cardiology




THERAPEUTIC AREAS


SERVICES

Clinical Analytics


SOLUTIONS


ClinicalStang

Medical Writing


ProjectManagement


SiteSelection


FunctionalServices


ENTCNS


Oncology


RegulatoryA�airs

Cardiology




THERAPEUTIC AREAS


SERVICES

Clinical Analytics


SOLUTIONS


ClinicalStang

Medical Writing


ProjectManagement


SiteSelection


FunctionalServices


ENTCNS


Oncology


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

ready for a cro that values performance over promises ...medical writing safety / pharmacovigilance...

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