AGILE SCIENTIFIC GROUP

Agile Scientific is a life sciences organization that brings decades of industry knowledge, expertise, processes, best practices, and systems to companies. Agile Scientific’s clinical services function to accelerate all facets of drug development, ensure compliance at a global level and optimize pipeline value / ROI..

Agile Scientific is fortunate to partner with smaller virtual organizations and Fortune 500 Life Sciences companies alike. We have extensive experience providing focused, pragmatic clinical solutions to our sponsor Life Science organizations and CRO’s across all areas of Drug Safety, Regulatory Affairs, HEOR / Pharmacoepidemiology, Quality Assurance.

AGILE SCIENTIFIC FUNCTIONAL SERVICE PROVIDER

Areas of Expertise:

Drug Safety & PV

  • Medical Review
  • Medical review
  • Safety Surveillance/singnaling
  • Safety Reporting
  • REMS/RMP
  • PV Epidemiology

Regulatory Affairs

  • Regulatory strategy
  • Advertising &Promotion
  • Labeling
  • CMC
  • Medical Writing

HEOR Market Access:

  • Observational Study Design
  • Economic Modeling
  • Global Value Dossiers
  • Pharmacoepidemiology
  • Pricing & Reimbursement

Quality Assurance:

  • GxP Internal & External Audits
  • PV Audits
  • Inspection Readiness
  • SOP Development
  • QMS

Drug Safety / Pharmacovigilance

A pharmacovigilance and drug safety expert from Agile Scientific acts as a direct extension of your team to assist with:
⦁ Clinical and Marketed Individual Case Safety Reports
⦁ Aggregate Safety Reports
⦁ Scientific Literature Surveillance
⦁ Safety Signal Detection
⦁ Epidemiology Consultation
⦁ Risk Management
⦁ Regulatory Consultation

Regulatory Affairs

Agile Scientific is well-positioned to provide a high impact regulatory affairs expertise to help deliver company-driven solutions in:

⦁ Regulatory Strategy
⦁ Regulatory Submission Planning
⦁ Advertising/Promotion Review and Compliance
⦁ Chemistry Manufacturing & Controls (CMC)
⦁ Product Labeling Development and Strategy
⦁ Medical Writing
⦁ Clinical Trial Authorizations, Maintenance, and Trial Support
⦁ Orphan Drug and Humanitarian Device Applications
⦁ Competitive and Regulatory Intelligence
⦁ Regulatory Authority Meeting Preparation and Facilitation
⦁ Pharmacovigilance Processes
⦁ Marketing Applications
⦁ Launch and Post-Approval Activities

Health Economics & Outcomes Research

Our Team Can Help:

⦁ Design Observational Studies
⦁ Develop various Pharmacoeconomic Models
⦁ Develop and Validate PRO Instruments
⦁ Conduct Retrospective and Prospective Database Studies
⦁ Develop Effective Global Value Dossiers
⦁ Deliver Publication Strategy, Abstracts, and Manuscripts
⦁ Perform Complex Epidemiological Statistical Analysis
⦁ Conduct Comprehensive Literature Reviews
⦁ Define HEOR Strategy For Access and Optimizing Demand
⦁ Provide Health Policy Expertise Concerning Changing Global HealthcareEnvironment

QA & Compliance

Our Quality Assurance practice can assist you with:

⦁ All aspects of GCP, GMP, and GLP auditing
⦁ Pharmacovigilance audits
⦁ Mock Audits & Inspection Readiness
⦁ Clinical Study Report review and auditing
⦁ Computer Systems Validation
⦁ Strategic Process Development
⦁ SOP and Protocol design, development, and review
⦁ CAPA development

Clinical Software – PATS

Patient Analysis and Tracker System, PATS, is a clinical outcomes, data management software system designed for clinical facilities to track and analyze outcomes for virtually any procedure or treatment

 

From cardiac surgery, cardiology, and vascular medicine to oncology, orthopedics, and transplant, PATS is an ideal outcomes tracking solution. Use PATS’ unparalleled follow-up to track long term outcomes and perform longitudinal analysis
PATS helps you efficiently harness your medical data for:

Data Ownership

While PATS harvests, audits, and packages data for registry submission, your data is stored locally. You have complete access at all times. You can use PATS’ rigorous, ad hoc data mining capability and its analytics with graphical output, to help achieve your clinical initiatives.

Customizable

PATS is fully customizable, allowing registry design and modification at no additional cost. PATS can accommodate existing and pre-defined databases, as well as completely user-defined data sets or registries. PATS’ open architecture allows you to build custom registries, each with unlimited data elements

Reporting

PATS’ built-in provides reports for quality and process metrics, and for report templates. You can use the reports out-of-the-box or you can easily customize built-in reports, and save them for monthly and quarterly monitoring. Ad hoc reporting is fast, easy, and flexible—you can select the fields and metrics for any patient population.

Analytics

PATS provides a structure that fosters exceptional reporting and analysis of clinical procedures, their efficacy, and long-term success. PATS analytics are ideal for clinical quality improvement, outcomes research, quality data management, and decision support. PATS’ built-in data mining and analytics tools make outcomes reporting a snap.

CONTACT US

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