A High Caliber Clinical Team

Infinitus Clinical Research Associates (CRAs) display professionalism and innovative problem solving skills based upon their extensive experience in the industry.

Our CRAs have experience in monitor everything from straightforward outpatient studies to large, complex in-patient studies in all phases of product development.

Infinitus CRAs ensure ICH/GCP compliance and data integrity at each site visit, consistently retrieving high-quality, on-time data.

Clinical Operations Services:

Ø  In-depth, therapeutic experience

Ø  Innovative leadership

Ø  Comprehensive training & development

Ø  Tactical planning & close communication

Ø  Commitment to employee growth and retention

Ø  Focus on detail

Ø  Demonstrated service and commitment to quality

Infinitus provides monitoring of clinical trials. At each monitoring visit, according to the project scope, CRAs will review and deal with

Ø  Protocol compliance

Ø  Case Report Form (CRF) accuracy and completeness

Ø  Serious Adverse Event (SAE) reporting to the required bodies

Ø  Tracking of mandatory reporting to Ethics Committees (IRBs) & regulatory authorities

Ø  Enrolment & suitability of patients

Ø  Trial progress & review strategy

Ø  Continued acceptability of investigator and facilities

Ø  Filing and maintenance of source documents

Ø  Investigational Product inventory and accountability records

Ø  Compliance of investigator’s document file

Ø  Collection of data for interim analysis where appropriate

Following each site visit, Infinitus prepares a monitoring report in accordance with Infinitus’ or the Sponsor’s SOPs as specified.

Communications

Ø  Infinitus works mainly with overseas based Sponsors, and often with sites in more than one country. This makes communication, not only formal reports, but also informal updates, critical.

Ø  Infinitus provides document translation where required.

Reporting, Filing & Archiving

Ø  Formal reporting, correspondence, filing and archiving are an important part of clinical trial work. Infinitus takes these responsibilities seriously and is focused on providing clearly and accurately reporting within the specified timeframe and keeping records in compliance with Sponsor and regulatory requirements.

 Site & Study Close-Out

Ø  At the conclusion of the study, the final data needs to be gathered, investigational products accounted for, and any outstanding issues resolved with sites

At this time, Infinitus CRA’s:

                      I.        Ensure Case Report Forms (CRF’s) and any queries or addenda are collected

                    II.        Complete an inventory of investigational product supplies

                   III.        Reconcile accountability and distribution forms

                   IV.        Review all relevant documentation

                    V.        Return investigational product supplies or destroy as required

                   VI.        Give final instructions to sites’ investigators and personnel

                 VII.        Ensure final reports and notifications go to Ethics Committees (IRBs) & Regulatory authorities

Infinitus works closely with the Sponsor during this process to ensure all data for the study is collected, reported and that compliance requirements for regulatory authorities and ethics requirements are met.