Phase 1 Studies

Only one. Between Convex and the Sponsor. Through additional internal contracts Convex arranges the conduct of the trial with third party vendors involved in the clinical trial.

It usually takes 1 business week. The whole process depends to a great extent on the Sponsor and their responsiveness. Based on our experience so far with small companies, the agreement process takes about 1 business week whereas with large pharmaceutical companies this process may take up to 24 calendar days. Depending on preference, Convex can also start work on the clinical project based on a signed Letter of Intent.

We can choose either approach depending on the Sponsor’s preference.

Once the clinical study agreement is signed, a clinical research manager is appointed who starts the communication with the Sponsor. He/she is the main point of contact between the Sponsor and all other third parties involved in the process.

After a clinical study agreement is signed, Convex starts working on the documents preparation to obtain an approval of the clinical trial by the Regulatory Authority and the Ethics Committee.

In the event that Convex receives a ready package of documents for submission to the regulatory authorities, the time to obtain an approval varies between 45-60 calendar days which includes: 10 calendar days to collect/adapt trial specific documents and 35- 50 calendar days for review and approval by the Regulatory Authorities.

In the event that Convex is directly involved in the development of the study protocol, informed consent and other clinical trial related documents this period is extended by an additional 20 calendar days for the documents preparation.

A list of documents varies depending on the type of the clinical trial and the clinical investigational medicinal product. Upon request, this list will be provided to you by our clinical project managers with further (additional) clarifications.

Yes. all fees are presented in the cost proposal for the trial in the pass-through costs section.

Yes, both documents are required. Convex is working with a vendor who can develop the Investigator’s Brochure in case it is not available.

Convex begins with the preparation of the clinical part which includes providing all necessary resources, organizing the clinical team and prescreening prospective eligible participants (subjects). Thus, once the site is initiated and the clinical trial starts, the research team begins with the screening of the participants (subjects). This approach significantly shortens the period between the clinical trial approval and first subject in. A standard of 24 participants are screened over a period of no longer than 3-4 working days. The screen failures during the screening process are also included in this period.

Yes. Depending on the trial design, we can dose 60 participants per week in a standard pharmacokinetic trial. Convex was able to recruit 780 participants (subjects) for a clinical study who have successfully completed the study.

The team consists of a Principal Investigator who is a clinical pharmacologist with experience in over 230 Phase 1 clinical trials, Sub-Investigators who are specialists in various medical fields and 14 nurses and lab technicians.

Yes, the team conducts an annual training related to procedures needed in the event of an acute deterioration of the trial participants’ medical status.

The site is equipped with all the equipment and medicines necessary to provide first aid. The site has contracted a medical company specialized in emergency transportation and a university hospital for the admission and treatment of clinical trial participants. A member of the team is an emergency medicine specialist.

Yes, we work with two Western European laboratories. Of course, if the clinical study Sponsor already has a preferred partner we contact that laboratory and start working with it.

Yes, our team of CRAs with over 5 years of experience in performing early phase trial monitoring covers this activity.

We have closed the circle of activities through local partners and cover all the services required in the clinical trial process. If the Sponsor has preferred vendors for any of the services, we at Convex will work directly with them. In this case the trial sponsor has a direct contractual relationship with their preferred company.

Convex uses eCRF to collect and process clinical trial data. Depending on the budget of the clinical trial, Convex offers two well recognizable data collection platforms.

As soon as the Last visit is monitored and verified. Usually this process takes place within 10 days after the subject’s visit or PK lab report is received. Once this activity is completed, the data is transmitted to a biostatistician who begins the preparation of the statistical report.

Within 20 working days after the database closure.

The final study report draft version is prepared within 10 calendar days after the completion of the biostatistical report.

It is submitted to the Sponsor for review. After a discussion and marking of comments, the Convex team continues to work on the document until it is finalized. This typically takes an additional 7 calendar days. Once all comments and issues are cleared, the final study report is completed and distributed (sent) to all responsible parties for signature and completion.