Our Services - Altitude Clinical Research

What Can We Do for You?

At Altitude Clinical Research, we provide end-to-end support for clinical trials so physicians can focus on patients
while sponsors can count on quality and compliance.

Hourly Services

Regulatory Services

IRB/IEC submissions and ICF development
Clinical Trial Agreement (CTA) coordination
Site and staff credentialing; FDA Form 1572
Regulatory binder creation & essential document tracking
Oversight of GCP compliance & delegation logs
Protocol deviation reporting
Audit/inspection readiness and sponsor support

Quality Assurance Services

Internal audits of source, CRFs, and binders
Oversight of protocol adherence
Deviation/CAPA tracking and resolution
Trend analysis and corrective action planning
CRC training for quality improvement

Data Services

CRF/EDC data entry and query management
Reconciliation of source, AE/SAE, and safety data
Data cleaning and review prior to lock
Imaging (RECIST), biomarker, and specialty data tracking
Privacy compliance and submission timelines

Investigational Product (IP) Services

IP receipt, inventory, and accountability
Temperature monitoring and excursion reporting
Dispensing, returns, and destruction documentation
Pharmacy logs, chain of custody, and SOP support
Preparation for audits and sponsor visits

Clinical Research Coordinator (CRC) Services

Patient screening, eligibility, and informed consent
Visit scheduling and coordination of procedures
Source documentation and data entry
AE/SAE reporting and query resolution
Protocol training and site support
Follow-up and ePRO/eDiary assistance

Administrative & Financial Services

Budget negotiation and coverage analysis
Contract management and cost-share modeling
Payment tracking, invoicing, and site disbursement
CTMS oversight and financial reporting
Startup and closeout cost management

Block Services - Study Startup

Altitude Clinical Research offers bundled startup packages for efficiency and predictability. Complex protocols (multi-arm, pediatric, device + drug) may require a custom quote.

Package

Startup Package (Basic)

Startup Package (Comprehensive)

Includes

Coverage analysis, Budget negotiation, CTA negotiation and coordination, startup cost tracking.

All above plus credentialing, regulatory binder creation, essential documents, IRB/IEC submission, ICF development/customization, IRB communication & revisions until approval

* Altitude Clinical Research collaborates with an experienced third-party vendor to provide specialized budget and contract services seamlessly within these packages.

Optional Add-On Services

QA Audit (Pre-study Readiness Check)
IP/Pharmacy Setup (storage SOPs, accountability, audits)
Additional Site Training Sessions