Biostatistics
Getting The Most Out of Your Data
provides expert biostatistics services for Phase I-IV clinical trials. Our top-tier biostatisticians are leaders in applying statistical concepts to design and execute efficient clinical trials. Supporting our clients from protocol design through regulatory submission and defense, our biostatistics team helps interpret your data so that you can make informed decisions about your clinical program.
Technology Solutions PHC leverages industry-leading technologies to complement our premium data services. Our preferred technology platforms include:
- iMedNet eClinical
- Medidata Rave
- Veeva Vault eTMF
In addition to these technologies, PHC frequently supports studies in a variety of other eClinical platforms upon client request.
Data Management/EDC
Specialized Services and Technologies for Your Study
When it comes to clinical trial success, data integrity is key. Our clinical data management experts are committed to providing the highest data quality, integrity, and security for our clients. Using industry-leading electronic data capture (EDC) technologies, PHC provides end-to-end clinical data management support from eCRF design through database lock and final study archival.
PHC is a CDISC Registered Solutions Provider for CDASH, Controlled Terminology, SDTM, ADaM, Define-XML, and Study/Trial Design Model standards.
Protocol Review
Optimal Technology Solution Recommendation
Risk-Based Monitoring Strategies
24/7 EDC Helpdesk
EDC Access Administration
Data Management Trial Master File Set-Up and Maintenance
CRF Design and Development
CRF Completion Guidelines (CCG) Development
Subject Diary Design and Development
Data Management Plan Development
Data Validation Manual Development
EDC System Training for Sites and Monitors
Clinical Database Creation, Validation and Auditing
Edit Check Programming, Validation, and Testing
Development of Custom Status Reports
Adverse Event, Concomitant Medication, and Medical History Coding
Import, Integration, and Cleaning of Electronic Data (Lab, ECG, PK, Diary, etc.)
Continuous Data Cleaning Throughout Study
Query Reconciliation
Independent QC Review
SAE Reconciliation between Safety and Clinical Databases
Database Lock
Study Archival
Interactive Response Technology (IRT)
Automating Randomization and Inventory Management
PHC’s IRT randomization services can make even the most complex clinical trials run smoothly and efficiently.
Also known as IWRS/IVRS (Interactive Web/Voice Response Systems), IRT automates your patient randomization, kit assignment, drug supply, and inventory management. Streamline your clinical trial with PHC’s comprehensive IRT solutions.
iMedNet eClinical
Medidata Rave RTSM (formerly Balance)
Endpoint Pulse
Almac IXRS3.0
For studies utilizing iMedNet eClinical, PHC internally performs all IRT development services. As experts in IRT services and solutions, PHC provides full project management/oversight from study start-up through closeout for all our IRT technology options.
Automated Randomization for Single or Multi-arm, Centralized or Multi-stratification, and Restricted & Forced Randomization
Inventory Management including Trigger-based Resupply, Predictive Resupply, and Drug Expiration Management
Seamless Integration with EDC/eClinical System
Comprehensive Field Level Blinding
Blinded and Unblinded Reporting
Emergency Unblinding
Customizable Inventory Statuses
Data Monitoring Committee Services
Helping You Make Informed Decisions
The Data Monitoring Committee (DMC) is an integral part of many clinical studies. PHC provides expert statisticians to analyze your data for safety review and DMC meetings.
Our team has supported DMC/DSMB meetings as subject-matter experts in a variety of therapeutic areas, including: Dermatology, Gastroenterology, Immunology, Infectious Disease, Neurology, Oncology, and Ophthalmology.
DMC/DSMB Data Services
Development of Stopping Rules
Independent Reporting Statistician
Voting Statistical Board Member
Charter Development/Authoring
Unblinded DMC Team Independent of Blinded Study Team
Table, Listing, Figure Development and Production
Rapid Turnaround of Ad-Hoc Requests
Integration of Pharmacovigilance Data
