Convex Clinical Research Center was designed and built to address all the needs of the clinical research process. With over 40 experienced clinical investigators our Clinical research center with phase 1 unit offer an excellent approach to early phase research. Convex phase 1 unit is designed and built to address all the needs of the clinical research process and to ensure quality medical care and safety standards. Open 24/7, it is custom-designed facility and it is focused on pharmacokinetic studies on healthy volunteers. Our dedicated team of pharmacologists and early phase clinical research team perform phase 1 studies on patient population with a spectrum of diseases. Before each study is initiated we ensure all protocol requirements are followed and Convex Phase 1 unit is in compliance with the appropriate guidelines and regulations.
The Phase 1 unit, centrally located in Sofia city, allowing Convex dedicated staff to progress within the process of recruitment and retention of volunteers and to constantly develop a database of study subjects for multiple types of clinical trials. Our phase 1unit is constructed in a way to facilitate phase 1 researchers to conduct studies for a new drug or treatment in a small group of people and to evaluate its safety, determine a safe dosage range and/or identify side effects. Our expertise includes First-In-Man (FIM) studies, escalating dose studies, interaction studies, PK/PD studies, bioequivalence studies, and early phase studies. Convex clinical research institution with Phase 1 unit is designed and equipped to ensure compliance and safety.
Convex research center provides emergency care specialists as well as specialized emergency medical transportation during treatment period for the save of our participants. In case of need, the clinical center maintains contract with an university hospital for unhindered and smooth emergency room accommodation and high-quality medical service. We have created a relaxed and comfortable environment where our study subjects successfully complete their participation and meet new friends and medical professionals they could rely on in future. A comfortable and clean environment, as well as maintaining of high-tech equipment, restful furniture and fun activities are elements for a full-comfort stay of our participants. Normally, our participants relax during their participation and gather pleasant stay memories. This approach allows us to complete our clinical projects without complications and constantly expand our healthy volunteer database on a monthly basis. The food during study treatment periods is of essential importance. By exceeding our participants expectation, we successfully manage to maintain nutritional quality and quantity from a dietetic perspective and in compliance to all protocol requirements. To achieve all that we collaborate with a specialized catering company that meets all medical requirements and authorized by the Ministry of Health in Bulgaria.
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.
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.
Before every Phase I trial, as well as assessing risk and justifying that assessment, there must be a strategy for ensuring that any risk is minimised throughout the trial. Should potential investigators be concerned about the level of risk of the IMP, the sponsor must give them access to people with responsibility for the relevant pre-clinical work. Also, the sponsor’s physician should liaise with the investigator. If investigators still have concerns about pre-clinical data, they should consult an independent adviser. Assessment and management of risks should be documented (e.g., through a risk management plan). The strategy for managing risk should consider all aspects of the trial. The majority of Phase I clinical trials use healthy subjects. This approach has the advantage of speed of recruitment and ease of scheduling cohorts of subjects throughout the study. It also removes potential confounding factors such as concomitant medication and disease pathology when reviewing adverse event and PK data. Healthy subjects may generally tolerate and facilities match the level of risk of the IMP. Investigators must not take on trials of an IMP for which they do not have adequate experience or training. The PI and unit staff responsible for the care of subjects in FIH clinical trials should always be appropriately qualified and experienced. The PI for a FIH trial has to meet specific training and experience requirements. The sponsor should ensure that the investigator knows enough about the agent, its target, mechanism of action and potential adverse events to be in a position to manage the informed consent process with the subject, and to make informed clinical judgments during the study. The investigator must also understand the intricacies of executing FIH trials, including the potential need to adjust doses during the study as human data become available. The investigator must assess the risk of harm, by reviewing the protocol, investigator’s brochure, IMP dossier, CTA application and, any relevant medical and scientific literature. In addition, the investigator must weigh the foreseeable risks and inconveniences against the expected benefits for the individual subject, and for future subjects with the target disease. Finally, the investigator must explain and justify any risks in the information leaflet for trial subjects and in the EC application. The sponsor should conduct a site evaluation to consider the site’s capabilities to meet the specific demands of a particular protocol such as appropriate medical governance, drug-specific biomarker methodologies or sample acquisition/ analysis, the ability to recruit study participants FIH clinical trials of IMPs with identified factors of risk should be conducted in research units with sufficient expertise and know-how. However, this does not negate the importance of a site-evaluation by sponsor staff. Site assessment by the sponsor staff should include, but not be limited to:
In FIH clinical trials where there is a predictable risk of certain types of severe adverse reaction, the sponsor should specifically address risk mitigation in the protocol, which should include considerations for treatment of such reactions. The sponsor and research site should ensure that any specific antidotes will be readily available, where they exist, as well as a clear plan of supportive treatment, including the pre-arranged contingency availability of intensive care facilities or specialty consultation. The research site should assess the study-specific requirements for clinical cover and ensure that an appropriate level of staffing, with medical doctors during and after dosing, will be present. For the FIH trials of IMPs other than those factors of risk, the sponsor should consider similar factors as previously discussed, on a case-by-case basis. As a minimum, the sponsor must assess facilities, training and experience of personnel, and the evidence that unit medical staff are appropriately qualified and trained in handling emergency situations. Finally, it is critical that subjects taking part in FIH clinical trials have not been recently exposed to other investigational products.
Convex CRC is a clinical research center with a built-in phase I unit in which we have the capabilities and expertise to conduct clinical trials in early phases. Convex center for early drug development is focused on the conduct of single-center clinical trials (Phase 1 Studies) on healthy volunteers and patient populations:
|Early phase clinical trial||Dedicated clinical research institution specialized in the conduct of early phase clinical trials focused on healthy volunteers and specific patient population clinical studies.|
|State of the art equipment||The research institution is equipped with all necessary equipment for the proper conduct of FIM, BE/BA, PK/PD studies.|
|Research quality service||We do make conscious decisions to commit to research requirements needed to build a sustainable research site. We constantly invest in quality systems to deliver quality data for the ultimate outcome of safe and effective new medical therapies. We commit daily to providing optimal care for study patients, following the regulations and self-regulating with the intent of quality improvement.|
|Clinical subject data base||Constantly increasing our study subject database consisting of large number of healthy volunteers and specific patient population. We are proud to make our study participants stay involved through-out the entire course of a studies as well as relaxed & happy.|
|Related clinical research services||Convex provides end-to-end services for our biotech/pharma/or generic companies. Starting from clinical study design to the development of final study report. All services under one company including safety lab and PK analysis, biostatistical and data management, medical writing, project management, clinical monitoring, regulatory and consultation, IP packaging. Convex research organization successfully manage all steps of the way through the final results by an already proven and effective approch for every sponsor.|