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Data Management
Our data management services include database design, build, and validation, as well as data cleaning, coding, and standardization.-
Consulting (strategic program planning, protocol review, EDC selection, etc.)
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Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides.
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Database design, development, and maintenance
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Data validation programming and testing, inclusive of edit check and manual review specifications.
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Data entry, if applicable
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Medical coding using WHODrug & MedDRA dictionaries
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Serious adverse event (SAE) reconciliation
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Management and integration of local laboratory reference ranges with CRF data
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Integration, verification and reconciliation of external electronic data
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Medical coding using WHODrug & MedDRA dictionaries
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EDC selection and end-user training
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Database lock and archival
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Database transfer
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Biostatistics
Our team of biostatisticians provides expert statistical consultation, analysis, and reporting to support our clients' clinical trials.-
Consulting (strategic program planning, protocol review, EDC selection, etc.)
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Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides.
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Database design, development, and maintenance
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Data validation programming and testing, inclusive of edit check and manual review specifications.
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Data entry, if applicable
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Medical coding using WHODrug & MedDRA dictionaries
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Serious adverse event (SAE) reconciliation
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Management and integration of local laboratory reference ranges with CRF data
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Integration, verification and reconciliation of external electronic data
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Medical coding using WHODrug & MedDRA dictionaries
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EDC selection and end-user training
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Database lock and archival
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Database transfer
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Clinical/Statistical Programming
We offer clinical and statistical programming services, including developing customized SAS and R code for generation of SDTM, ADaM, and TFLs.-
Consulting (strategic program planning, protocol review, EDC selection, etc.)
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Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides.
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Database design, development, and maintenance
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Data validation programming and testing, inclusive of edit check and manual review specifications.
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Data entry, if applicable
-
Medical coding using WHODrug & MedDRA dictionaries
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Serious adverse event (SAE) reconciliation
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Management and integration of local laboratory reference ranges with CRF data
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Integration, verification and reconciliation of external electronic data
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Medical coding using WHODrug & MedDRA dictionaries
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EDC selection and end-user training
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Database lock and archival
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Database transfer
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Data Analytics and Visualization
Our data analytics and visualization services include the development of interactive dashboards and reports using tools such as R Shiny, Spotfire, and Tableau.-
Consulting (strategic program planning, protocol review, EDC selection, etc.)
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Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides.
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Database design, development, and maintenance
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Data validation programming and testing, inclusive of edit check and manual review specifications.
-
Data entry, if applicable
-
Medical coding using WHODrug & MedDRA dictionaries
-
Serious adverse event (SAE) reconciliation
-
Management and integration of local laboratory reference ranges with CRF data
-
Integration, verification and reconciliation of external electronic data
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Medical coding using WHODrug & MedDRA dictionaries
-
EDC selection and end-user training
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Database lock and archival
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Database transfer
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CDISC Data Standards Implementation
Our data management services include database design, build, and validation, as well as data cleaning, coding, and standardization.-
Consulting (strategic program planning, protocol review, EDC selection, etc.)
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Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides.
-
Database design, development, and maintenance
-
Data validation programming and testing, inclusive of edit check and manual review specifications.
-
Data entry, if applicable
-
Medical coding using WHODrug & MedDRA dictionaries
-
Serious adverse event (SAE) reconciliation
-
Management and integration of local laboratory reference ranges with CRF data
-
Integration, verification and reconciliation of external electronic data
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Medical coding using WHODrug & MedDRA dictionaries
-
EDC selection and end-user training
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Database lock and archival
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Database transfer
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Medical Writing
Our medical writing services include the development of clinical study reports, protocols, and regulatory documents such as the Clinical Study Report (CSR), Investigational New Drug (IND), and New Drug Application (NDA).-
Consulting (strategic program planning, protocol review, EDC selection, etc.)
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Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides.
-
Database design, development, and maintenance
-
Data validation programming and testing, inclusive of edit check and manual review specifications.
-
Data entry, if applicable
-
Medical coding using WHODrug & MedDRA dictionaries
-
Serious adverse event (SAE) reconciliation
-
Management and integration of local laboratory reference ranges with CRF data
-
Integration, verification and reconciliation of external electronic data
-
Medical coding using WHODrug & MedDRA dictionaries
-
EDC selection and end-user training
-
Database lock and archival
-
Database transfer
-
-
Consulting (strategic program planning, protocol review, EDC selection, etc.)
-
Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides.
-
Database design, development, and maintenance
-
Data validation programming and testing, inclusive of edit check and manual review specifications.
-
Data entry, if applicable
-
Medical coding using WHODrug & MedDRA dictionaries
-
Serious adverse event (SAE) reconciliation
-
Management and integration of local laboratory reference ranges with CRF data
-
Integration, verification and reconciliation of external electronic data
-
Medical coding using WHODrug & MedDRA dictionaries
-
EDC selection and end-user training
-
Database lock and archival
-
Database transfer
-
Consulting (strategic program planning, protocol review, EDC selection, etc.)
-
Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides.
-
Database design, development, and maintenance
-
Data validation programming and testing, inclusive of edit check and manual review specifications.
-
Data entry, if applicable
-
Medical coding using WHODrug & MedDRA dictionaries
-
Serious adverse event (SAE) reconciliation
-
Consulting (strategic program planning, protocol review, EDC selection, etc.)
-
Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides.
-
Database design, development, and maintenance
-
Data validation programming and testing, inclusive of edit check and manual review specifications.
-
Data entry, if applicable
-
Medical coding using WHODrug & MedDRA dictionaries
-
Serious adverse event (SAE) reconciliation
-
Management and integration of local laboratory reference ranges with CRF data
-
Integration, verification and reconciliation of external electronic data
-
Medical coding using WHODrug & MedDRA dictionaries
-
Consulting (strategic program planning, protocol review, EDC selection, etc.)
-
Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides.
-
Database design, development, and maintenance
-
Data validation programming and testing, inclusive of edit check and manual review specifications.
-
Data entry, if applicable
-
Medical coding using WHODrug & MedDRA dictionaries
-
Serious adverse event (SAE) reconciliation
-
Management and integration of local laboratory reference ranges with CRF data
-
Consulting (strategic program planning, protocol review, EDC selection, etc.)
-
Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides.
-
Database design, development, and maintenance
-
Data validation programming and testing, inclusive of edit check and manual review specifications.
-
Integration, verification and reconciliation of external electronic data
-
Medical coding using WHODrug & MedDRA dictionaries
-
EDC selection and end-user training
-
Database lock and archival
-
Database transfer
What we do better
At Clymb Clinical, we are committed to providing customized solutions that meet our clients' specific needs and ensure the successful completion of their clinical trials. By using this model, companies can access a broad range of specialized expertise and resources without incurring the overhead costs and management challenges of building an internal team.
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Cost Savings
Companies can reduce their overhead costs by outsourcing specific functions or tasks to external service providers, rather than building an internal team.
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Access to specialized expertise
Companies can access a broad range of specialized expertise and resources through external service providers, allowing them to complete complex tasks more efficiently and effectively.
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Scalability
The FSP model allows companies to scale their resources up or down based on project needs, without incurring the overhead costs of maintaining a full-time team.
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Increased Focus
By outsourcing specific functions or tasks, companies can focus their internal resources on core competencies and strategic initiatives, rather than on peripheral functions.
Got Questions? We've Got Answers
What is an FSP model?
An FSP model is a type of outsourcing model that allows companies to outsource specific functions or services to a third-party provider.
What are the benefits of using an FSP model for clinical trial data?
The benefits of using an FSP model include cost savings, increased flexibility, and access to specialized expertise.
What types of services can be outsourced using an FSP model?
Services that can be outsourced using an FSP model include regulatory services, staffing, clinical IT, clinical data management, biostatistics, Phase 1 through 4 trials, clinical trial supplies, and central labs.
How does an FSP model differ from other outsourcing models?
An FSP model differs from other outsourcing models in that it allows companies to outsource specific functions or services rather than entire projects or programs.
What are the key considerations when selecting an FSP provider for clinical trial data?
The key considerations when selecting an FSP provider include the provider’s experience and expertise in the specific area being outsourced, their ability to provide flexible solutions that meet your needs, and their ability to work collaboratively with your team.
You have different questions?
Dont worry! our team will answer it for you.
