We are more than a traditional CRO. Besides providing typical
traditional
CRO services and having a strong experience in Real World Evidence projects, we have developed an
innovative registry model that unlocks the power of data and collaboration, effectively engaging physicians.
Our network is composed of high volume and quality focused electrophysiologists, which by itself is an important competitive advantage. We have detailed
knowledge about the procedure volumes, procedural characteristics, complication and
success
rates of each one of the sites in our network.
Registry-based Collaborative
We are more than a traditional CRO. Besides providing typical
traditional
CRO services and having a strong experience in Real World Evidence projects, we have developed an
innovative registry model that unlocks the power of data and collaboration, effectively engaging physicians.
Our network is composed of high volume and quality focused electrophysiologists, which by itself is an important competitive advantage. We have detailed
knowledge about the procedure volumes, procedural characteristics, complication and
success
rates of each one of the sites in our network.
Registry-based Collaborative
We are more than a traditional CRO. Besides
providing typical
traditional
CRO services and having a strong experience in Real World Evidence projects, we have developed an
innovative registry model that unlocks the power of data and collaboration, effectively engaging physicians.
Our network is composed of high volume and quality focused electrophysiologists, which by itself is an important competitive advantage. We have detailed
knowledge about the procedure volumes, procedural characteristics, complication and
success
rates of each one of the sites in our network.
Traditional CRO Services
We offer CRO services to a wide spectrum of clients,
ranging
from
large medical device companies to small and mid-size start-ups.
We support pre-market
(e.g.,
IDE) and post-market clinical
studies with clinical project management, data management, data monitoring, clinical site management, etc.
Traditional CRO Services
We offer CRO services to a wide spectrum of clients,
ranging
from
large medical device companies to small and mid-size start-ups.
We support pre-market
(e.g.,
IDE) and post-market clinical
studies with clinical project management, data management, data monitoring, clinical site management, etc.
Traditional CRO Services
We offer CRO services to
a wide spectrum of clients,
ranging
from
large medical device companies to small and mid-size start-ups.
We
support pre-market
(e.g.,
IDE) and post-market clinical
studies with clinical project management, data management, data monitoring, clinical site management, etc.
Services Offered (Clinical Research Support Services by Study
Stage)
.
Step 1: Design
Step 2: Start-Up
Step 3: Execution
Step 4: Close-Out
Data Management
eCRF design
Study-specific EDC training/user manuals
Database development and programming
Data management plan
Data monitoring plan
Site training on EDC and data collection
Data review and cleaning
Resolve data queries
Database lock
Biostatistics
Clinical study design
Protocol development
Randomization schedule
Statistical analysis plan development
Interim data analysis and creation of tables, figures, etc.
Annual report analysis
DSMB reports
Statistics results
Data interpretation
Clinical study reports
Publications
Regulatory meetings
Study Management
Selection of central IRB and submission for protocol level approval
Protocol
Informed consent
Publications
CMS approval application
Investigator/site selection
Contract/budget negotiation
Site initiation visits
IP distribution
Subject enrollment
Data collection
Site monitoring visits
DSMB/CEC management
TMF management
Site payments
Close-out visits
Final device accountability
RBC
Registry Based Collaboratives
Our network is composed of the most productive
electrophysiologist in the country, which by itself is an important competitive
advantage. We have detailed knowledge about the procedure volumes, procedural
characteristics, complication and success rates of each one of the sites in our
network.
Physician
Engagement
Our team works closely with our network of
physicians, utilizing implementation science to engage physicians in the
generation and uptake of new evidence, and by doing so democratizing
scientific
production.
Our main focus is on optimizing the
generation of
Real World Evidence.
Scientific
Production
Our engaged physicians collaborate, share and discuss best practices, evolving the standard of care and suggesting
pragmatic
"embedded" studies. Our team helps physicians by providing them with the tools
to
implement their research ideas, by helping to define the study/trial design, providing medical writing and statistical expertise.
RWE
Real World Evidence Studies
Our main
focus
is
on optimizing the generation of Real World Evidence.
Our Real
World Evidence projects are typically implemented through our collaborative
network
of over 64+ hospitals.
We provide
cost
effective, multi-center, compliant studies (both prospective and retrospective )
that
can be used for a multitude of uses such as:
Publications
Post-Approval studies
Label Expansion
Publications
Post-Approval studies
Label Expansion
RBC
Registry Based Collaboratives
Our network is composed of the most productive
electrophysiologist in the country, which by itself is an important competitive
advantage. We have detailed knowledge about the procedure volumes, procedural
characteristics, complication and success rates of each one of the sites in our
network.
Physician
Engagement
Our team works closely with our network of
physicians, utilizing implementation science to engage physicians in the
generation and uptake of new evidence, and by doing so democratizing
scientific
production.
Our main focus is on optimizing the
generation of
Real World Evidence.
Scientific
Production
Our engaged physicians collaborate, share and discuss best practices, evolving the standard of care and suggesting
pragmatic
"embedded" studies. Our team helps physicians by providing them with the tools
to
implement their research ideas, by helping to define the study/trial design, providing medical writing and statistical expertise.
RWE
Real World Evidence Studies
Our main
focus is
on optimizing the generation of Real World Evidence.
Our Real
World Evidence projects are typically implemented through our collaborative
network
of over 64+ hospitals.
We provide
cost
effective, multi-center, compliant studies (both prospective and retrospective )
that
can be used for a multitude of uses such as:
Publications
Post-Approval studies
Label Expansion
Publications
Post-Approval studies
Label Expansion
Registry Based
Collaboratives
Our network is composed of the most productive
electrophysiologist in the country, which by itself is an important competitive
advantage. We have detailed knowledge about the procedure volumes, procedural
characteristics, complication and success rates of each one of the sites in our
network.
Physician
Engagement
Our
team works closely with our network of physicians,
utilizing implementation science to engage physicians
in the generation and uptake of new evidence,
and by doing so democratizing scientific production.
Our main focus is on optimizing the
generation of
Real World Evidence.
Scientific
Production
Our engaged physicians collaborate, share and discuss best practices, evolving the standard of care and suggesting
pragmatic
"embedded" studies. Our team helps physicians by providing them with the tools
to
implement their research ideas, by helping to define the study/trial design, providing medical writing and statistical expertise.
Real World Evidence
Studies
Our main
focus
is
on optimizing the generation of Real World Evidence.
Our Real
World Evidence projects are typically implemented through our collaborative
network
of over 64+ hospitals.
We provide
cost
effective, multi-center, compliant studies (both prospective and retrospective)
that
can be used for a multitude of uses such as:
