Szasz&Co. Bt

Phone: +36203321142

Fax: +3622784631

E-mail: info@szaszcro.eu; kornelia.szasz@szaszcro.eu

Web: https://szaszcro.eu/

Szász&Co. Bt is a privately owned boutique Clinical Research Organization located in the central region of Hungary. We are providing multimodal services for our pharmaceutical, biotechnology and medical device partners throughout development of the newest medical therapies.

The main focus of company is to provide scientific and technical assistance and monitoring services for our clients to conduct their clinical trials successfully in Hungary, starting from site selection until site closure. We have an excellent working relationship with investigators in numerous therapeutic areas.

Our philosophy is to ensure that we work pursuing the highest quality standards for human health. Our main ambition is to assist our clients to carry out clinical trials successfully from concept to completion. You will receive undivided attention, stable timelines and predictable expenses for your project.

We have close to 15 years experience in global monitoring of phase I-IV clinical trials and device studies in a wide range of therapeutic areas including cardiology, oncology, gastroenterology, nephrology, pulmonology, ophthalmology, pediatric trials in Hungary. We also have been providing clinical oversight services for more than 5 years.

Our services:

1. Country and site feasibility procedure

• We have an extensive database regarding investigative sites and investigators at most therapeutic areas.

We can provide you with most appropriate information regarding country and site level feasibility of your clinical trial

1. Site and investigator selection

• We can guarantee to select the most appropriate investigators for conducting clinical trials of our partners based on our extensive investigator database and long term  working experience regarding Hungarian medical doctors working in most therapeutic areas. Our rate of enrolling, successful sites selected is 85% in our previous practice.
• We ensure the adequacy of facility and equipment at selected sites according to requirements of clinical trial to be conducted. We collect all necessary maintenance and calibration documentation of devices to be used in trial. 

3. Site set-up:

• We have solid experience in the preparation of regulatory submission package according to country specific requirements
• We provide support in  customization of ICF and its translation and also Protocol Synopsis, patient facing documents and professional review of translation before submission
• We manage regulatory submission via the Hungarian Governmental Client Gate system.
• As native Hungarian contact, we manage regulatory affairs via effective communication with Hungarian authorities during the evaluation process.
• We assist our partners in budget negotiations and contract preparation with shortest timelines.
• We provide support in collecting, creating, reviewing and approving all clinical trial documentation, including original regulatory documentation necessary for Investigational Product release.

1. Site management:

• Study initiation:

Excellent site initiation guarantees smooth and high quality study conduct.

We ensure that site will start trial conduct as fully trained with all necessary accesses and supplies available according to requirements of Sponsor and ICH-GCP

• Site monitoring
  • Our goal is to ensure adequate support for sites to conduct clinical trial according to requirements of Protocol, Sponsor and ICH-GCP guidelines
  • We guarantee to keep all requested timelines
  • We ensure proper safety reporting
  • Sites managed by us will deliver data in adequate quality and in timely manner for interim and final database locks
  • We guarantee high quality and up-to-date documentation at site and also in Trial Master File
• Center close-out without any outstanding issues

1. Providing clinical oversight services

Clinical oversight is one of the main responsibilities of sponsors during conducting clinical trials according to ICH-GCP E6 R2. If your company assigned an external service provider to manage clinical trial conduct, it is essential to ensure that your trial is delivered with the highest quality standards and in agreed timeframes. Clinical oversight specialists can guarantee that the CRA and CRO you have selected work effectively following the requirements of Protocol, Sponsor and ICH-GCP guidelines. We ensure inspection readiness in clinical trials providing clinical oversight for. 

Mission:

• Our mission to support our clients to carry out clinical trials in Hungary from concept to completion. Our philosophy is to strive for the highest quality standards of human health.

About us:.

• We have close to 15 years experience in managing phase I-IV clinical trials and device studies in a wide range of therapeutic areas including cardiology, gastroenterology, nephrology, pulmonology, oncology, ophthalmology, pediatric trials.
• We are providing scientific and technical assistance for our clients to conduct their clinical trials successfully in Hungary from site selection until site closure. We have an excellent working relationship with a wide range of investigators of numerous therapeutic areas.

We have also been providing clinical oversight services for more than 5 years.

For detailed contact information visit location pages below.