Our Services

overview
CRA Solutions, Inc. is a Full-Service Contract Research Organization offering complete global clinical trial management services:
  • Product Plans/Evaluations
  • Clinical Operations and Crisis Management
  • Protocol Development & Study Tools
  • Monitoring (On-Site and Remote)/Monitoring Performance Assessments and Training
  • Data Management & Statistics
  • Auditing & BIMO Preparation
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overview
CRA Solutions, Inc. is a Full-Service Contract Research Organization offering complete global clinical trial management services:
  • Product Plans/Evaluations
  • Clinical Operations and Crisis Management
  • Protocol Development & Study Tools
  • Monitoring (On-Site and Remote)/Monitoring Performance Assessments and Training
  • Data Management & Statistics
  • Auditing & BIMO Preparation
Learn More
STUDY RESCUE
CRA Solutions offers intensive Study Rescue to Companies in crisis. We develop plans to mitigate risks, develop and implement CAPA plans with metrics to demonstrate securing of compliance.
We offer consulting and auditing services for studies facing major issues with protocol/GCP compliance, monitoring and data management. We will help you get back on track for CE Mark/FDA approval.
DATA MANAGEMENT & STATISTICS
Data management issues are a source of delays for many clinical trials. CRA Solutions ensures the collection, integration and availability of data at appropriate quality and cost. We offer CRF and eCRF design, database building (in many systems), data entry/review, and on-demand data analysis. Our experienced report writers will prepare professional, submission-ready clinical study reports and data. We are also experienced with eSource and web-based applications from building to validation.
AUDITING & BIMO PREPARATION/SUPPORT
CRA Solutions provides auditing services at both the sponsor and investigator level. With our extensive experience, we can assess processes, determine responsibilities, identify and resolve noncompliance, reduce costs, establish documentation, and improve overall efficiency.
CRA Solutions uses a BIMO…
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monitoring
At CRA Solutions, we use the MRM Step Method to ensure high quality monitoring. The MRM Step Method is a systematic approach to monitor training that encourages critical thinking and thorough documentation. We understand that experience alone is not enough to guarantee effective monitoring, so we provide our CRAs with the…
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PROJECT & CLINICAL OPERATIONS MANAGEMENT
CRA Solutions is involved in all aspects of developing and implementing new clinical trials: protocol design, FDA strategy meetings, SOPs, training, regulatory submissions, etc.
A cross-functional clinical operation plan is the key…
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REGULATORY SUBMISSIONS & STRATEGY
A product plan can be developed to determine the regulatory strategy to FDA clearance/approval. This assessment includes the type of testing pre or clinical, if existing data can be used to submit to the FDA, if a predicate device can be used for clearance. CRA Solutions works closely with…
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CONSULTING
START-UP SERVICES
CRA Solutions provides a customized, comprehensive approval strategy and project planning consulting services to companies large and small. We are dedicated to launching your project and seeing it through FDA approval.
Our consulting services include:
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INVESTORS & VENTURE CAPITAL
No matter the stage of your project, CRA Solutions offers realistic perspective and goal-oriented planning.
Our consulting services include:
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SITE SUPPORT & TRIAL MASTER FILE MANAGEMENT
We facilitate communication and coordination between the sponsor, sites, CRA’s, IRBs, and other parties (e.g. vendors, safety committees and outside data management). We help develop processes to ensure action item resolution and accountability documentation.
Sites often struggle with complex...
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SITE SUPPORT & TRIAL MASTER FILE MANAGEMENT
We facilitate communication and coordination between the sponsor, sites, CRA’s, IRBs, and other parties (e.g. vendors, safety committees and outside data management). We help develop processes to ensure action item resolution and accountability documentation.
Sites often struggle with complex...
Learn More