Our Approach
Our Approach
Our Approach
Our turnkey solution takes the headaches out of clinical trial management
Select on any of the buttons below to learn more.
Patient Identification
CRA’s holistic patient recruitment approach leverages our extensive network of disease researchers, and patient advocacy groups to assemble a strategy to match the patient to your clinical trial based on your study’s criteria.
For targeted therapeutics, we use biomarker-driven screening to find the patients expected to respond to your therapeutic, moving quickly and with confidence in data quality thanks to our in-house speciality lab services.
Clinical Trial Planning
We collaborate with you to develop efficient and informative
clinical development plans.
Biostatistics
Medical Writing
Data Management
Medical & Safety
Monitoring
Market Access &
Positioning
Specialty Labs /
Transitional
Sciences
Oversight and Management
From start to finish, both on-site and off, our processes and
personnel ensure quality, safety, and efficiency.
-
In-depth implementation procedures
mitigate risk and establish
comprehensive study-specific plans and
documentation.
-
Highly consistent processes and rigorous
study-specific training reduce error and
deliver reliable study data.
-
Collaborative engagement with both you
and key site personnel ensures accurate
study execution.
-
Experienced CRAs work on only 1-2
projects, making them study-site experts
for your study.
Data Review & Analysis
To maintain compliance with the FDA and other regulatory agencies, we expedite the delivery of clinical study data into SDTM and ADaM format.
-
We work with internal and external sites and monitors to review, trend, query and clean data on an ongoing basis.
-
Our robust processes, SOPs and technology allow us to delivery ongoing feedback on entry and monitoring.
-
We provide transparency so you can make data-driven decisions to move your clinical program forward.
Regulatory Management
We do all the documentation and reporting.
-
Our services include the responsibility of all the documentation aspects of the protocols.
-
CRA obtains IRB approval in an expedited manner, keep and transfer all research data, file all regulatory papers and compliance documentation that are necessary to conduct each individual trial.
-
CRA make our mobile nursing/clinical personnel available to facilitate compliance with all protocol requirements and to assist the investigator and sub-investigators in conducting the specific trial.
Frequently Asked Questions Coming Soon
Ready to Get Started?
Clinical Trial Planning
Clinical Trial Planning
We collaborate with you to develop efficient and informative clinical development plans
Oversight and Management
Medical & Safety Monitoring
Market Access & Positioning
Speciality Labs / Transitional Sciences
We collaborate with you to develop efficient and informative clinical development plans.
Biostatistics
Medical Writing
Data Management
Regulatory Management
From start to finish, both on-site and off, our processes and personnel ensure quality, safety, and efficiency.
-
In-depth implementation procedures mitigate risk and establish comprehensive study-specific plans and documentation.
-
Highly consistent processes and rigorous study-specific training reduce error and deliver reliable study data.
-
Collaborative engagement with both you and key site personnel ensures accurate study execution.
-
Experienced CRAs work on only 1-2 projects, making them study-site experts for your study.
Data Review and Analysis
To maintain compliance with the FDA and other regulatory agencies, we expedite the delivery of clinical study data into SDTM and ADaM format.
-
We work with internal and external sites and monitors to review, trend, query and clean data on an ongoing basis.
-
Our robust processes, SOPs and technology allow us to delivery ongoing feedback on entry and monitoring.
-
We provide transparency so you can make data-driven decisions to move your clinical program forward.
We do all the documentation and reporting.
-
Our services include the responsibility of all the documentation aspects of the protocols.
-
CRA obtains IRB approval in an expedited manner, keep and transfer all research data, file all regulatory papers and compliance documentation that are necessary to conduct each individual trial.
-
CRA make our mobile nursing/clinical personnel available to facilitate compliance with all protocol requirements and to assist the investigator and sub-investigators in conducting the specific trial.
Frequently Asked Questions
Coming Soon
Ready to Get Started?
Our turnkey solution takes the headaches out of the clinical trial management
Click on any of the buttons below to learn more
Patient Identification
CRA’s holistic patient recruitment approach leverages our extensive network of disease researchers, and patient advocacy groups to assemble a strategy to match the patient to your clinical trial based on your study’s criteria.
For targeted therapeutics, we use biomarker-driven screening to find the patients expected to respond to your therapeutic, moving quickly and with confidence in data quality thanks to our in-house speciality lab services.
Clinical Trial Planning
We collaborate with you to develop efficient and informative clinical development plans.
Oversight and Management
From start to finish, both on-site and off, our processes and personnel ensure quality, safety, and efficiency.
-
In-depth implementation procedures mitigate risk and establish comprehensive study-specific plans and documentation.
-
Highly consistent processes and rigorous study-specific training reduce error and deliver reliable study data.
-
Collaborative engagement with both you and key site personnel ensures accurate study execution.
-
Experienced CRAs work on only 1-2 projects, making them study-site experts for your study.
Data Review and Analysis
To maintain compliance with the FDA and other regulatory agencies, we expedite the delivery of clinical study data into SDTM and ADaM format.
-
We work with internal and external sites and monitors to review, trend, query and clean data on an ongoing basis.
-
Our robust processes, SOPs and technology allow us to delivery ongoing feedback on entry and monitoring.
-
We provide transparency so you can make data-driven decisions to move your clinical program forward.
Regulatory Management
We do all the documentation and reporting.
-
Our services include the responsibility of all the documentation aspects of the protocols.
-
CRA obtains IRB approval in an expedited manner, keep and transfer all research data, file all regulatory papers and compliance documentation that are necessary to conduct each individual trial.
-
CRA make our mobile nursing/clinical personnel available to facilitate compliance with all protocol requirements and to assist the investigator and sub-investigators in conducting the specific trial.
Get in touch.
Questions? Are you ready to get started? Leave us a message and some of your contact info and a CRA representative will in touch with you shortly.
Follow Us
Why CRA?
Solutions
Get In Touch
Why CRA?
Solutions
Sponsors
Get In Touch
Schedule a Consultation
Privacy Notice
Terms and Conditions
© 2023 Clinical Research Alliance. All rights reserved.