Trialwise
Trialwise is a woman-owned contract research organization (CRO) founded in 1999, specializing in Phase I and II clinical studies. As a boutique CRO, it functions as an extension of a sponsor’s organization, ensuring the clinical trial process is managed expertly and efficiently with a focus on quality, accuracy, and regulatory compliance. The company emphasizes personalized service, innovation, and leveraging the latest technology to meet the demands of drug development. Trialwise is committed to providing outstanding service to a limited number of clients, primarily referrals and long-standing sponsors, and aims to deliver high-quality, personalized, and efficient clinical trial management.
Industries
Nr. of Employees
small (1-50)
Products
Staffing Support
Clinical research staffing services to quickly add top flight people and capabilities to drug development teams.
Biostatistics Services
The Trialwise approach to quality data begins with cross-functional collaboration to design custom CRFs and SAPs for our sponsors early in the process.
Augmented Services
Flexible augmented services for clinical trials.
Clinical Operations Services
Clinical operations services providing proactive study management, site identification, central IRB submissions, risk-based monitoring, site management, and investigational product management to ensure trials adhere to timelines and budgets.
Medical Writing
Clinical and regulatory medical writing services.
Data Management Services
Comprehensive clinical data management services including CRF design and guidelines, database design, build, and validation, edit check programming, data management plans, and data cleaning and coding.
Staffing Support
Clinical research staffing services to quickly add top flight people and capabilities to drug development teams.
Biostatistics Services
The Trialwise approach to quality data begins with cross-functional collaboration to design custom CRFs and SAPs for our sponsors early in the process.
Augmented Services
Flexible augmented services for clinical trials.
Clinical Operations Services
Clinical operations services providing proactive study management, site identification, central IRB submissions, risk-based monitoring, site management, and investigational product management to ensure trials adhere to timelines and budgets.
Medical Writing
Clinical and regulatory medical writing services.
Data Management Services
Comprehensive clinical data management services including CRF design and guidelines, database design, build, and validation, edit check programming, data management plans, and data cleaning and coding.
Services
Operational CRO services for planning and executing Phase I/II clinical trials, including study management, monitoring, site management, TMF oversight, and investigational product logistics.
Clinical data services including CRF design, database build and validation, edit check programming, data cleaning, coding, and data management plans.
Statistical consulting and deliverables including SAP development, sample size calculations, statistical programming, analyses, TLF generation, and CDISC‑compliant datasets.
Preparation of regulatory and clinical documents including protocols, investigator brochures, IND support, clinical study reports, safety narratives, and electronic publishing for submissions.
Temporary and long‑term placement of clinical research professionals and biometrics staff to support projects or supplement sponsor teams.
Supplemental services including niche consulting, quality assurance and audits, medical monitoring, pharmacovigilance, and safety narrative preparation.
Operational CRO services for planning and executing Phase I/II clinical trials, including study management, monitoring, site management, TMF oversight, and investigational product logistics.
Clinical data services including CRF design, database build and validation, edit check programming, data cleaning, coding, and data management plans.
Statistical consulting and deliverables including SAP development, sample size calculations, statistical programming, analyses, TLF generation, and CDISC‑compliant datasets.
Preparation of regulatory and clinical documents including protocols, investigator brochures, IND support, clinical study reports, safety narratives, and electronic publishing for submissions.
Temporary and long‑term placement of clinical research professionals and biometrics staff to support projects or supplement sponsor teams.
Supplemental services including niche consulting, quality assurance and audits, medical monitoring, pharmacovigilance, and safety narrative preparation.
Expertise Areas
- Clinical trial management
- Early‑phase (Phase I/II) clinical development
- Clinical operations and site monitoring
- Biostatistics and statistical programming
Key Technologies
- SAS programming
- CDISC SDTM
- CDISC ADaM
- DEFINE.xml
News & Updates
Trialwise supported SRI International in developing an oral treatment for internal radioactive contamination, providing clinical operations, data management, biostatistics, and medical writing services for the Phase 1 trial of HOPO 14-1.
Trialwise supported Skye Bioscience in a Phase 1 trial of SBI-100 Ophthalmic Emulsion, which was well tolerated in healthy volunteers, marking the first human trial of an ophthalmic drug targeting the CB1 receptor.
Trialwise implemented its proprietary risk-based monitoring framework in a multicenter Phase 1 HIV study, demonstrating the feasibility of risk-adaptive monitoring for smaller, multicenter, early-phase trials.
Trialwise supported SRI International in developing an oral treatment for internal radioactive contamination, providing clinical operations, data management, biostatistics, and medical writing services for the Phase 1 trial of HOPO 14-1.
Trialwise supported Skye Bioscience in a Phase 1 trial of SBI-100 Ophthalmic Emulsion, which was well tolerated in healthy volunteers, marking the first human trial of an ophthalmic drug targeting the CB1 receptor.
Trialwise implemented its proprietary risk-based monitoring framework in a multicenter Phase 1 HIV study, demonstrating the feasibility of risk-adaptive monitoring for smaller, multicenter, early-phase trials.