Services

The selection of the best investigational sites is key factor in the success of clinical trials. All efforts are made to use objective indicators that will minimize assessment errors. The following key elements are rigorously checked:

• Expertise and experience of the Principal Investigators (PI) and the staff;
• Qualification and training of the staff in required domains;
• Availability of the staff even well qualified and trained;
• Availability of the potential PI to oversee studies even well qualified and trained staff;
• Infrastructures and equipment;
• Quality Management system including quality assurance (QA) and quality control (QC);
• Potential of recruitment with clear recruitment plan;
• Potential risk of competition in recruitment and staff workload;

We have the capability to accompany research institutions or clinical sites that plan to be developed to meet standards for running clinical trials.

1. Per ICH GCP definition, the clinical monitoring is “the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirements” E6 1.38
2. Our CRA are qualified, appropriately trained and well mentored to go beyond the expectations of the sponsor normally put in an approved Monitoring Plan (MP). For all monitoring activities, CRAs always comply with standards of ICH/GCP and local applicable regulations.
3. ICRA will perform for you with the highest possible quality the following monitoring activities:
   • Site pre-study visits;
   • Site Initiation visits;
   • On-site and/or remote Interim monitoring visits;
   • Site Close Out visits;
   • Site visits for preparation to audit and inspection.
4. Our CRAs strive to check where applicable these main aspects:
   • The rights, the safety and well-being of human subjects are protected because are the most important considerations and should prevail over interests of science and society;
   • The conduct of the trial is in compliance with the currently approved protocol/amendment (s), with GCP, with applicable regulatory requirements and with SOPs;
   • The approved version number/date of informed consent form is used and signed correctly;
   • All essential documents are filled;
   • The reported trial data are accurate, complete and verifiable from source documents (SDV);
   • The adverse events and concomitant medications are adequately and timely reported;
   • The requested lab samples are properly collected, handled, tested and stored;
   • The investigational products are appropriately received, stored, dispensed with a reconciled accountability.
5. We will honestly and appropriately report to the sponsor, all performed activities in the agreed timelines put in the Monitoring Plan. All findings are rigorously followed-up until resolution and a concerted plan to avoid re-occurrences is always put in place.

Smart Planning for Time and Budget

All efforts should be done to complete entire clinical trial process on time and on budget. We have the capacity to work closely with the sponsor to reach this fundamental goal.

ICRA can fully or partially manage your project depending on what you decide to hand out. All project management activities undertaken will be in compliance with the agreed project management plan, the study protocol, standard operating procedures, ICH-GCP guidelines and applicable local regulations. To maximize chances of success, we will perform for each project the followings activities:

• Develop and maintain timelines and resources;
• Develop and maintain study deliverables and milestones;
• Communicate closely and sincerely with sponsors and key study support stakeholders to install durable trust;
• Organize periodic project management committee meetings;
• Assess and Manage the risks;
• Plan the resolution of emergent issues;
• Supervise the entirety of activities and execution of related budget.

All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation, and verification. E6 2.10

Data management includes all aspects of capturing, handling and receipt of data, for the purpose of clinical research.

ICRA strives to ensure the integrity of data through ALCOA to ultimately guarantee credible results for your projects. All the preceded preoccupations are integrated in valuable data management plan to save time and speed-up the processes.

ICRA can validly assist you on:

• Development of Data Management Plan;
• Development of CRF and/or eCRF;
• Data entry;
• Development of edit checks;
• Management of queries;
• Data cleaning;
• Quality Assurance (QA) and Quality Control (QC);
• Database lock and audit;
• Generation of tables and listings;
• Generation of reports;
• Database transfer.

ICRA staff characterized by the multidisciplinarity is skilled to assist you to develop and/or review:

• Protocols;
• Participant inform sheet and participant informed consent forms;
• Investigator Brochures;
• Diary cards;
• Advertising tools;
• Clinical Trial reports;
• Study manuals;
• Scientific posters and papers;
• Monitoring plan.

ICRA can also offer translation of scientific documents from English to French or French to English.

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ICRA offers trainings sessions in:

• Good Clinical Practice (GCP);
• Good Clinical Laboratory Practice (GLP);
• Ethics;