Szasz&Co. is a boutique Clinical Research Organization

located in the central region of Hungary.

We are providing support for our pharmaceutical, biotechnology and medical device partners throughout the development of the newest medical therapies.

We are providing support
for our pharmaceutical, biotechnology and medical device partners throughout
the development of the
newest medical therapies.

Focus
We are providing 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 focus
We are providing 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.

Focus
We are providing 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.

Mission
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.

Mission
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.

Mission
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.

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

Experience
We have close to 15 years of experience in supporting management 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 have also been providing clinical oversight services for more than 5 years.

We provide study set-up in Hungary from concept to completion

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

We can select the optimal site and investigator for your needs.

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.

Site set-up

We prepare regulatory submission package according to country specific requirements

We provide support in translation of Protocol Synopsis, ICF and patient facing documents and professional review of translation before submission

We manage 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 provide proper support in budget negotiations and contract preparation with shortest timelines.

We provide assistance in collecting, creating, reviewing and approving all clinical trial documentation, including original regulatory documentation necessary for Investigational Product release.

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

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.

Our services

Country and site feasibility procedure

Site and investigator selection

Site set-up

Site management

Clinical oversight services

To read the full description of our services, click here:

Our services

Country and site feasibility procedure

Site and investigator selection

Site set-up

Site management

Clinical oversight services

We have

an extensive database regarding investigative sites and investigators
the most appropriate information regarding country and site level feasibility

To read the full description of our services, click here:

Why select us?

As boutique CRO we provide special and dedicated care for your trial.

We have good relationship with an extended group of healthcare professionals in several therapeutic areas

We have good relationship with
an extended group of healthcare professionals in several therapeutic areas

We have good relationship with an extended group of
healthcare professionals in several therapeutic areas

We have solid knowledge of local regulations beside
ICH-GCP guidelines, Helsinki Declaration FDA CFR

We have solid knowledge of local regulations beside ICH-GCP guidelines, Helsinki Declaration FDA CFR

We have an excellent working relationship with representatives of
regulatory authorities and ethics committees.
We can support effective and successful communication
between Hungarian authorities in case any issue emerged.

We have an excellent working relationship with representatives of regulatory authorities and ethics committees. We can support effective and successful communication between Hungarian authorities in case any issue emerged.

We have an excellent working relationship with
representatives of regulatory authorities and ethics committees.
We can support effective and successful communication between Hungarian authorities in case any issue emerged.

Write us a message to start working together!