Service Packs and Modularity

Q-Trials wide range of services can be grouped into cost-effective packages to fit your study and budget. All packages are modular and can be tailored according to your needs.

Feasibility and Site Selection Package
Regulatory Submissions Package
Monitoring Package
Trial Logistics Package
Translations Package



Feasibility and Site Selection Package

Q-Trials proactively suggests preferable sites for specific research areas. We perform feasibility assessments of dozens of sites a year. We are much experienced in assessing recruitment potential, investigator motivation and compliance and adequate site personnel and facilities. We save our Sponsors time and money by recommending only suitable sites. We have excellent relations with the sites we work with and keep deepening our connections with other sites. We integrate the information collected on a feasibility assessment with our acquaintances, internal knowledge and previous experience. 
Regulatory Submissions Package

Q-Trials regulatory-related activities are our bread and butter. We like defining the regulatory strategy of a study and planning the regulatory pathway ahead, in parallel with detailing the process for the client. Then we go through with the actual initial submission and continue with routine site submissions. You can use this service together with a Monitoring Package, or use it separately. This package also includes contract handling and budget negotiations as well as study insurance consultation.

Monitoring Package

Q-Trials employs a team of monitoring professionals: CRAs, and project managers to overlook the execution of the monitoring plan. Our team members have advanced academic degrees in relevant disciplines and have extensive experience in different positions within study teams acquired throughout the years.

This is our classic package, most sought by our Sponsors. The backbone of this package consists of what our CRAs do routinely: Site identification and selection, Informed Consent Form review and adaptation, regulatory submissions, site set up and initiation, patient eligibility, source data verification, site personnel training, drug accountability, query resolution, SAE and safety reporting etc. Our CRAs make sure the sites adhere to timelines – protocol requirements and applicable regulations. Our CRAs are also experienced with Remote Monitoring and off-site support.

The Project Management addition lends you the services of a delegated person to look after all aspects of your study. The PM supervises the clinical study team, is responsible for the CRAs performance, will maintain communication flow between the client and the study team, sites and vendors. The PM will have a general study overview, and will make sure timelines are kept, milestones are achieved and the study budget is not overrun.

A PM can be hired within the Monitoring Package by clients who opt for the full hierarchy of a study team. Our PMs are also hired by Israeli clients to supervise studies conducted abroad. A favorite package combination with our clients would be combining all of the above with the Logistics Package, for a one-stop-shop deal.  

Trial Logistics Package

Q-Trials offers trial logistics and depot services to biomedical companies and CROs. We ensure efficiency and compliance in the handling of IMP, device, lab kits and other study supplies for clinical trials. Q-Trials provides all logistics services, including import and storage of investigational products as per product requirements (controlled conditions), dispatch and delivery, collection from sites and the destruction or return of products, as well as product accountability, inventory, quality check and re-labeling and kit assembly. All services are provided while adhering to local regulatory requirements and client SOPs.

Translations Package

Q-Trials in now a certified translator in accordance with the EN 15038 standard.
Our translations department consists of medical professionals who are well acquainted with the terminology of clinical trials. Being a CRO, we understand your professional needs, and make sure translations are in compliance with local regulations as well as client SOPs and study-specific terminology.

We translate into Hebrew, English, Arabic and Russian. We deliver a top quality product within excellent timelines and competitive pricing. We offer a complete translation process: translation, verification, back-translation, QC and certification. We routinely translate: Informed Consent Forms, patient information leaflets, patient diaries, patient cards and questionnaires, Instructions for Use, LEC and MoH submissions and approvals, package inserts and product labels.