Effective Research
A contract research organization (CRO) based in Hollywood, Florida providing clinical development services to pharmaceutical, biotechnology and medical device clients. Services described include end-to-end clinical trial management (Phase I–IV), clinical monitoring, project management, data and statistical management, quality assurance, feasibility assessments and remedial (rescue) trial services. The site states staff have multi-year industry and trial experience and that teams are assigned as multidisciplinary units for study execution.
Industries
Nr. of Employees
small (1-50)
Effective Research
Products
Clinical Development Services
Comprehensive clinical development services provided to pharmaceutical, biotechnology, and medical device companies across major therapeutic areas.
Clinical Trial Management Services
Full clinical trial management services from inception to conclusion, or specific parts of a project to supplement your research requirements.
Clinical Development Services
Comprehensive clinical development services provided to pharmaceutical, biotechnology, and medical device companies across major therapeutic areas.
Clinical Trial Management Services
Full clinical trial management services from inception to conclusion, or specific parts of a project to supplement your research requirements.
Services
On-site and regional monitoring by CRAs providing SDV, consent verification, CRF review, SAE evaluation, drug accountability and site reports; monitors receive study-specific training and follow study SOPs and GCP.
Clinical project management including primary sponsor contact, scope/schedule/budget control, management of CRAs, central IRB and lab selection, regulatory documentation and regular sponsor reporting.
Independent QA audits and quality system development and review guided by GCP and federal regulations, for sponsors and contractors.
Rapid setup of remediation plans for trials with performance issues, implementation of intensive corrective measures and use of investigator networks to accelerate recovery.
Feasibility analyses including enrollment, screen-failure and retention forecasting, risk and contingency planning, and indication-specific operational recommendations.
Data management operations, e-CRF oversight, coordination with statisticians and statistical reporting for clinical studies.
On-site and regional monitoring by CRAs providing SDV, consent verification, CRF review, SAE evaluation, drug accountability and site reports; monitors receive study-specific training and follow study SOPs and GCP.
Clinical project management including primary sponsor contact, scope/schedule/budget control, management of CRAs, central IRB and lab selection, regulatory documentation and regular sponsor reporting.
Independent QA audits and quality system development and review guided by GCP and federal regulations, for sponsors and contractors.
Rapid setup of remediation plans for trials with performance issues, implementation of intensive corrective measures and use of investigator networks to accelerate recovery.
Feasibility analyses including enrollment, screen-failure and retention forecasting, risk and contingency planning, and indication-specific operational recommendations.
Data management operations, e-CRF oversight, coordination with statisticians and statistical reporting for clinical studies.
Expertise Areas
- Clinical trial management (Phase I–IV)
- On-site and remote clinical monitoring
- Project and program management for clinical studies
- Clinical data management
Key Technologies
- Electronic data capture (e-CRF)
- Source data verification (SDV)
- Central IRB coordination
- Central laboratory coordination