Mutare offers a full range of customized global and therapeutically aligned clinical services from start-up and conduct through closeout and analysis across all phases of clinical development. We are dedicated to providing customized end-to-end solutions to meet our clients’ project needs.
Mutare’s team works under several operating models to produce high-quality deliverables in support of our clients’ clinical development programs.
Explore our service offerings. If you don’t see your project need listed contact us for a customized solution.
Clinical Data Management
Mutare provides Clinical Data Management services from clinical database design and deployment through data validation to database lock, archival, and reporting.
Data Management Functional Leadership
Program Project Management
eCRF Design and Testing
eCRF Completion Guidelines
Database Design and Deployment
Data Handling/Management Plans
Query Generation, Resolution, and Trend Analysis
Medical Review Support
SAE Reconciliation and Safety Review Support
3rd Party Vendor Data Transfer Specifications and Reconciliations
Database Lock and Archival
Oversight of Outsourced Data Management Vendors
For other project needs contact us for a customized solution
Clinical Operations
Mutare provides Clinical Operations services focused on study and site management from planning and startup through closeout and reporting.
Clinical Operations Functional Leadership
Program Project Management
Study Plan Development (Project Management, Communication, Study Startup, Monitoring Plans)
Clinical Trial Planning and Management
Clinical Trial Budget Management
Site Feasibility and Startup
Site Management
Monitoring
Collaborating on Protocols and Clinical Study Reports
Development of Informed Consents/Assents and Site-Facing Documents
Drug Supply Management
IVRS/IWRS Oversight
eTMF Oversight
Vendor Management and Oversight
For other project needs contact us for a customized solution
Biostatistics and Statistical Programming
Mutare provides essential Biostatistics and Statistical Programming services for clinical study design, analysis, and reporting.
Biostatistics
Protocol Development
Clinical Study Design (Sample Size Calculation, Randomization, EndPoint Development)
Developing Analysis Dataset Specifications
Creating Statistical Analysis Plans including Mock-Shell Development
Statistical Oversight SDTM and ADaM datasets and TLFs
Performing Exploratory Analyses
Trial Simulations
Adaptive Design Feasibility and Planning
Publication Support
Functioning as the Blinded or Unblinded DMC Statistician
Post-Marketing Data Analyses, Reporting, Publications
Oversight of Outsourced Biostatistics Vendors
For other project needs contact us for a customized solution
Statistical Programming
Programming and Development of SDTM and ADaM datasets and TLFs
Edit Check Programming and Testing
Preparing Patient Profiles
Programming of PK Datasets, PK Merge and PK/PD Calculation
Preparing Patient Summaries for Narratives
Performing Exploratory Analyses
Preparation of Submission-Ready Documents and Packages (Define.xml, aCRF, SDRG, Pinnacle 21)
eCTD Submission Support
Programming of ISE/ISS and SCE/SCS
Performing Predictive Modeling
Oversight of Outsourced Programming Vendors
For other project needs contact us for a customized solution
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Medical Writing
Mutare provides Medical Writing services to write, edit, and lead document development for a broad range of document types required during preclinical through clinical development to post-marketing and commercialization.
Protocols, Protocol Concept Documents
Informed Consents/Assents
Investigator Brochures
Clinical Study Reports
Subject Narratives
Investigational New Drug Applications
Submission Documents including eCTD Clinical Modules in NDAs and CTAs
Investigational Medicinal Products Dossiers
Integrated Summaries of Safety/Effectiveness
Pediatric Study Plans, Pediatric Investigation Plans
For other project needs contact us for a customized solution
Specialty Services
Mutare also provides functional focused specialty services in the areas of CDM, ClinOps, Bios, SP, and MW in support of submission-related inspection preparedness, asset acquisitions, mergers and integration of processes, and business continuity solutions.
Quality Assessments and Compliance Evaluations for any deliverable in any functional area
Evaluations for Data Quality, Data Integrity
Quality Assessments for Operating Models, Database Migrations, Submission Documents Package
Compliance Evaluations for Regulatory Requirements (ICH, GCP) such as CRO Oversight
Inspection/Submission Preparedness and Risk Assessments
Validation of Vendor Proposals, Change Orders
Prepare Presentations for Regulatory Agency, Board or Investor Meetings, of the Clinical Development, Regulatory and/or Statistical Plans
CDISC Implementation and Governance
For other project needs contact us for a customized solution
