Scientific Medical and Strategic Consulting
Early collaboration with our senior staff saves both time and money. We can assist you in developing a plan for your investigational product and advise your company on the best strategy to pursue for your investigational product. Services include:
- Selecting best indication
- Determining experimental trial design (I.E. crossover, blind, placebo, etc.)
- Evaluating geographical considerations
Study Design
Early input into study design can greatly reduce the timelines necessary to complete the trial, earning you valuable revenues downstream.
Our experts can assist in:- Experimental design
- Defining the study hypothesis
- Reducing placebo effect through study design
- Optimizing sample size
- Strategic population
- Advising on protocol development
- Writing the protocol
Project Management
Our dedicated, highly-skilled Project Managers have extensive experience in a wide array of therapeutic areas. Our team of Project Managers are efficient in:
- Identifying sponsor goals and objectives and to recruit investigators accordingly
- Project timeline management and tracking
- Ethics board submissions
- Standardized site training and education
- Organizing investigator meetings
Clinical Monitoring
Our team of Clinical Research Associates (CRAs) has vast therapeutic and clinical research expertise. Organized, dedicated study teams allow for standardized monitoring and accountability. In addition, our CRAs receive regular training and continual professional development. Clinical monitoring activities include:
- 100% Source Document monitoring
- Query resolution to ensure Good Clinical Practice (GCP) compliance, protocol compliance, and accurate data collection
- Electronic query resolution through IDEMS
- Ensure protocol and regulatory compliance of study sites
- Serious adverse event (SAE) management
- Relationship-building with investigators and study staff
Data Management
Our data management team with the assistance of Global IQ’s Internet Data Entry Management System (IDEMS) provides:
- database design and development
- CRF design, development and tracking
- data validation
- data entry
- data query management
- adverse event (AE)/concomitant medication coding
- SAE management
- document archiving
From the IDEMS database, our biostatistics group can provide data analysis and statistics reporting presented in comprehensive report tables.
Quality Assurance & Regulatory Affairs (QARA)
Global IQ’s QARA department consists of experienced in-house personnel as well as experienced advisors.
Quality Assurance
Global IQ has a fully developed Quality Management System, which is illustrative of our commitment to providing quality services and products to our clients. Our Quality Assurance (QA) team conducts internal audits and management reviews as mandated in our procedures. Also in accordance with our procedures our QA team manages our Corrective and Preventive Action system (CAPA).
Global IQ SOPs have been developed in accordance with Good Clinical Practices (GCP), FDA (including CFR Title 21 Part 820 Quality System Regulation), TPD regulations, and the basic elements of ISO 9000. During annual internal audits our SOPs are audited for adequacy and effectiveness, as well as compliance with regulatory requirements.
Clinical trial project plans are built upon the solid procedures we have established, if required project-specific SOPs may also be developed. In addition, Global IQ has created an impressive collection of controlled forms upon which study information may be recorded and reported. These forms are designed to capture the quality records required for all aspects of clinical research.
To ensure investigational sites are following the protocol, GCP and regulations, and to ensure proper site management by the CRA, our QA team conducts investigational site QA audits.
Also to ensure
Global IQ uses highly qualified vendors, our QA team conducts Vendor
Qualification Audits.
Specific services available to clients by our QA team include:
• Standard Operating Procedures (SOPs) creation or review of client’s
quality system
•
Conducting In-House Training Sessions to Client’s staff
• Topics include:
(custom designed training sessions also available to meet your needs)
- Overview of drug development and clinical phases
- GCP Training
- Monitoring
- Adverse Events (AEs)
- Human Protection
- Regulatory Inspections
• Conducting vendor qualification audits of client’s vendors
• Conducting internal audits of client’s company departments
• Conducting investigational site QA audits
• Preparing investigational sites for upcoming regulatory inspections
Regulatory Affairs (RA)
Global IQ’s Regulatory Affairs (RA) team offers regulatory support
for both sponsors and investigators to ensure compliance with applicable
regulations.
Global IQ’s RA team will submit and maintain your regulatory application
to the agency you wish to use (e.g., the FDA, TPD, ANMAT, etc.); including the
submission of expedited SAE reporting to regulatory authorities. Our RA team
is also available to review protocols, informed consent forms and other study
related materials.
We work with our investigators to process successful submissions to their local
ethics boards and ensure proper site regulatory documentation.
Specific services available to clients by our RA team include:
• Regulatory strategy for client’s investigational product development
•
Submit and maintain regulatory applications (e.g. CTA to TPD and/or
IND to FDA).
• Including safety reporting management
• Liaison with regulatory authorities
• Review of protocol, informed consent forms and other study related
materials