Clinical Research

At N&Sz StudyMaster, we offer top-tier clinical research management services, delivering dependable outcomes with swift timing at competitive rates.

Our Phase Studies, including Phase I-IV clinical trials, showcase our prowess in collaborating with European and USA-based sponsors. Our achievements include being recognized as top recruiters, cultivating stellar relationships with sponsors, adept study management, and site teams, along with outstanding audit outcomes. We excel in the meticulous conduct of First in Human Phase I studies.
First in Human Phase I studies conduct and management.
Non-Interventional Studies / Late Phase/Patient Support Programs
We excel in orchestrating extensive patient support programs and non-interventional studies. Our work has been featured in prestigious scientific publications, demonstrating our commitment to excellence in the field.
Investigator Initiated Trials (IIT)

Investigational Medicinal Product (IMP) trials

Clinical Operation,
Start UP – feasibility, regulatory services, contract negotiation and management
Clinical monitoring (on site, remote, risk base, query resolution)
IP Management including Logistics
AE/SAE Management
Document, File Management (including eTMF set up and maintenance)
Closure procedures management
Archiving

Medical Device trials

Expertise in medical device trials is a hallmark of N&Sz StudyMaster CRO, spanning the cardiovascular, vascular, orthopedics, urology, and neurology sectors. Our comprehensive knowledge covers feasibility, pre-market, and post-market studies across class I – III devices, adeptly managed within the MDR (REG (EU) 2017/745) framework.

Managing medical device trials includes but not limited to:

Clinical Operation,
Start UP – feasibility, regulatory services, contract negotiation and management
Clinical monitoring (on site, remote, risk base, query resolution, IMP management)
AE/SAE Management/ Safety Management Services
Document, File Management/ TMF / Records Management Services (including eTMF set up and maintenance)
Closure procedures management
Archiving

Clinical Monitoring Services

Our Clinical Research Associates (CRAs) and other team members are thoroughly trained, bringing extensive experience to every aspect of clinical monitoring in line with SOPs, current regulations, and ICH-GCP standards. Our team’s therapeutic acumen spans a multitude of clinical research projects, handling the full spectrum of protocol development to full project management across Phase I to Phase IV trials, including Late-Phase and Non-Interventional Study Services.

Experience of staff includes but not limited to the following activities:

Feasibility studies
Assisting in Start-up, Contracting and Regulatory procedures (Essential Document Collection&review)
Pre-study Site Evaluation and Investigator Assessments (Site Selection)
Site Initiations / Trainings
Managing subject recruitment
Clinical Monitoring in Clinical Trials including Risk-Based and Remote Monitoring ensuring that the site is always audit ready
Monitoring and Management of Non-Interventional Studies / Late Phase Trials
Communication with the sites
Site IMP Management (Blinded & Unblinded)
Managing protocol deviations
Pharmacovigilance / Safety Management
Site Close-out activities
Filing & Archiving
Quality Assurance, management of Contracted Audits
Translation and translation verification services

Project Management

Our seasoned project managers offer expert clinical trial management, whether it’s within a single country or on a global scale. They immerse themselves in all facets of the trial, supporting the clinical team in gathering pivotal data to meet clinical and medical objectives while providing ongoing training.

Project Management includes, but not limited to:

Project planning feasibility – Quality by Design and kick off
- preparation of study materials – forms, logs, templates, documents
- establishment of documentation for regulatory and ethics approval supporting the regulatory team (set up and management of TMF and Files, documents of the project)
- creation of study plans
- training of clinical operation and study site team
Project Specific SOP development, amendment
Organizing, conduct and follow up of Investigator Meetings
- regular contacts with the study management/sponsor
Overall management of study conduct from feasibility to archiving, with comprehensive reporting,
- supporting CRAs and the sites in CAPA management
- overseeing timelines and budget
- Vendor Management choosing and managing vendors
- Project Tracking creating reports

Clinical Team / Line Management

We provide line management for clinical teams, ensuring CTAs, CRAs, SCs, and other staff are adeptly managed to fulfill the established goals.

The LM is responsible for:

Ensuring that the education and experience of the study team fit to the sponsor/partner requirements.
Providing, ensuring, and supervising the completion of the necessary trainings
Evaluating team and personal performances with coaching and performance feedback
Ensuring quality standards

Start-up and Contracting Management

Our regional networks and expertise enable swift, effective site selection for projects. We guarantee rapid and comprehensive results in feasibility and site selection, with a seamless process between regulatory and clinical teams for document collection.

Our contract specialists leverage strong site relationships to expedite contract finalization, propelling studies from initiation to patient recruitment as efficiently as possible.

Our goal is to bring the study up to the site initiation and patient recruitment phase in the shortest time possible.

Regulatory Services

We ensure swift trial approvals and continuous regulatory support, free from audit findings. Our regulatory team maintains excellent connections with authorities and ethics committees, offering full submission preparation and maintenance throughout the trial.

Regulatory Services includes:

Preparation and submission of initial trial application
Management of questions
Management, submission of amendments (substantial and non-substantial)
Submission of SUSARs, Safety Measures, Clinical Study reports and other documents
Communication with Competent Authorities, ethics committees and stakeholders
Training in regulations

TMF / Records Management Services

As clinical trials grow in complexity, our skilled TMF team ensures impeccable management, focusing on quality and compliance with a keen eye for detail, whether dealing with paper or electronic TMFs (eTMFs).

Each TMF team member went through comprehensive document recognition and quality assessment training. Our people are working either with paper or with electronic TMF (eTMF).

Medical Monitoring / Protocol Design / Medical Writing Services

Our Medical Monitors bring over 25 years of clinical research leadership to a broad spectrum of therapeutic areas. Their roles are critical to our success and include:

Support protocol development design, risk assessment
Reviewing all trial documents
Supporting/advising Investigator team at sites
Supporting management of emergency cases
Reviewing efficacy and safety trends in a trial
Providing therapeutic are and protocol trainings

The medical writing is the responsibility of our medical monitor. This includes
documents supporting regulatory submissions.

Safety Management Services

We adeptly handle SAEs, ensuring time-efficient, regulation-compliant responses. Our Phase I-III Drug Safety services are testament to our commitment to patient welfare.

Drug Safety services for Phase I-III development include:

SAE reporting
SAE processing
Narrative writing
Medical review
Lab and diagnostics test review
Safety report distribution and submission
Expertise in all major systems
On-site training in pharmacovigilance and risk management

Data Management and Statistics (via established contracted vendor cooperation)

Data Management is integral to study management. N&Sz StudyMaster partners with a seasoned Data Management firm in Hungary, offering comprehensive services, including database setup, CRF design, EDC system implementation, data quality assessment, and continuous system validation.

Quality Assurance

Quality assurance is the foundation for controlled trial studies. Our QA system features regularly updated SOPs, with adherence to ICH-GCP, and regional and local regulations. We prioritize a proactive QA approach, keeping all study elements audit-ready. Our team’s rich experience in audits informs our ‘lessons learned’ discussions, coupled with regular QA and SOP training.