I2R personnel have 20+ years of developing new drugs, including experience in clinical development and regulatory affairs. Most of this experience has been with small to medium sized companies, where members of our team assist our clients with their drug development planning.  This includes selection of indication(s) to pursue, clinical trial design, consideration of what countries to work in, and project budgeting.  We also assist our clients by identifying and bringing together key thought leaders for protocol focus groups and Clinical/Scientific Advisory Boards.  Additionally, several of our associates have worked at the FDA and/or presented before the FDA, as well as ex-US regulatory agencies.  We have experience with fast-track development programs and working with orphan drug compounds.

I2R is committed to producing high-quality electronic submissions in the Common Technical Document (CTD) format. We find this to be cost-effective for our clients, and at the end of the day, e-submissions allow for ease of document sharing with future partners.  We have considerable expertise in electronic publishing via the FDA’s Electronic Submissions Gateway.  We have the capacity to turn word documents into eCTD compatible pdf documents, complete with required hyperlinking, bookmarks, and document tagging.  We manage initial submissions as well as follow-on submissions, providing our clients with continuity and quick turnaround.  

We have a proven process management system focused on efficient delegation of responsibility and meeting tight timelines.  Again, we can complement our client’s teams by bringing in content experts – quality/CMC,  nonclinical, pharmacology, and clinical.

I2R manages all aspects of clinical trial conduct for our clients, from study start-up through issuance of a final study report.  We match an I2R project manager to meet specific client/project requirements.  Our clients benefit from our extensive site and investigator relationships, as well as vendor selection and management experience.  We utilize a web-based project management hub that enables all team members to be “on the same page” no matter where they sit.  We excel at team building, and that includes the study management team and the sites.

Site Selection & Start-Up

I2R works with our clients to ensure the selection of productive sites.  This means identifying sites that have a track record for enrolling subjects and generating good quality data.  We believe that the key to completing a trial on time – in addition to a well-designed protocol – is having enough sites, and to that end, we continue to identify sites until the last subject is enrolled.  Our site start-up procedures include a site qualification visit, collection of all essential regulatory documents prior to drug shipment, and site training (either through a site initiation visit or investigator meeting). 

Our associates have worked extensively throughout North America and Western Europe and have successfully collaborated with vendors for central labs, bioanalytical labs, central ECG labs, drug packaging and distribution, and central IRBs/ECs.  Our experience ensures that we meet or exceed our clients’ critical timelines.

Site Monitoring

Site monitoring serves two very important purposes: 1. To ensure our clients’ studies are being performed in accordance with all FDA and ICH regulations/ guidelines, and 2. To build strong relationships with the investigators and site staff on behalf of our clients – our team is your front line! We provide the following types of monitoring visits for our clients: Site Qualification, Site Initiation, Interim Monitoring, Unblinded Drug Accountability, and Study Close-Out.  Our CRAs average 15 years experience across a variety of therapeutic areas and many have held senior positions within biopharma companies.  All are trained to work with a variety of EDC systems and several of our CRAs are fluent in Spanish.

Data Management

I2R Data Managers can work with a variety of EDC systems, however our preferred system is Prism® (Nextrials, Inc., San Ramon, CA), a fully integrated, validated, and 21 CFR Part 11-compliant EDC system.  I2R personnel meet or exceed industry standards for database build (including EDC screen design), with a focus on the end user.

Our Data Managers are not just box checkers.  They have years of experience working with sites and CRAs, and know that good communication with the clinical team results in better data. 

Biostatistics and Pharmacokinetics

In many ways Phase I and proof-of-concept studies are the most important in the drug development process.  Asking the right questions early and turning analyses around quickly, results in good decision making for future studies. I2R has experience with a variety of statistical designs. Our statisticians and pharmacokineticists have extensive industry experience and are sensitive to the constraints of small biopharma companies.  We work in a “design efficient manner” to maximize limited financial and patient resources. I2R uses the industry standard WinNonLin® for PK analyses and SAS® for all statistical analyses.

GCP Auditing

I2R provides our clients with trained GCP auditors to conduct site audits, CRO audits, and sponsor audits.  We believe that, in addition to ensuring regulatory compliance and preparing for FDA audits, an audit is a training opportunity.  Our approach to auditing not only effectively assesses compliance and risk, but helps facilitate process improvement for our clients.

I2R’s medical writing team consistently produces high-quality documents including: IND/CTA modules, investigational medicinal product dossiers (IMPD), investigator brochures (IB), protocols, consent forms (including translations), clinical study reports, and study manuscripts.  All of our documents are produced in accordance with FDA and ICH guidelines.  All documents are made available in both MS Word and Adobe PDF formats, and all can be produced for electronic submission.  Additionally our team produces study-related training material for investigators and site staff.