Clinical Monitoring & Auditing
Services

With over 25 years of international experience in designing and delivering clinical studies, at 3S Pharma we offer custom made A to Z services for our partners needs. 

We do not settle for less, that is why  our Clinical Monitoring & Auditing Services are designed to ensure the highest standards of quality and quality control, compliance, and patient safety throughout every phase of a clinical study. 

Through our innovative problem solving solutions, personalized for impeccable outcomes, we create meticulous clinical monitoring and auditing designs to add value, consistency and quality control to each and every study. 

Either we develop an on-site monitoring design, a remote monitoring one, a centralized monitoring or a risk-based monitoring (RBM), our comprehensive solutions cover all types of monitoring in clinical trials, tailored to meet the specific needs of our clients and regulatory requirements.

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Our experienced team of scientists and other professionals provides crossover Bioequivalence (BE) and Bioavailability (BA) studies services to large, complex, steady-state BE and BA study services. That is how our experts in monitoring and auditing clinical trials assist in quality control with the purpose to preserve the integrity of the clinical study, comply with regulations and standards regarding operating procedures (SOPs)  and patients’ safety.

With increasing demands for flexibility, our team delivers scalable remote site monitoring in clinical trials, supported by secure digital platforms and other advancements in technology (artificial intelligence, machine learning, predictive monitoring, advanced analytics etc).

Our medical monitoring in clinical trials ensures ongoing safety evaluations, with real-time tracking of protocol deviations and adverse event monitoring in clinical trials. Our team collaborates closely with investigators to uphold participant safety and data integrity.

As for our auditing service, our team conducts both routine and for-cause audits covering clinical sites, trial master files etc). We align our processes with global standards to ensure audit-readiness and regulatory confidence.

What sets us apart from the rest of CRO?

More than 1500 studies successfully implemented

The studies we design are personalized for clients located on 3 Continents and over 20 0 countries (Germany, Italy, France, as well as other EU countries, Canada, India etc.).

Continuous scientific work internationally proven

A sustained scientific activity is performed by our researchers as proved by a series of relevant international publications and by the participation in public research projects in cooperation with other institutions (Universities, National Research Centers).

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Innovative technologies

3S Pharma has integrated the latest technology and AI in many areas that are designed for a clinical study.

Positive outcome claiming good compliance

Proven by over 100 audits conducted by customers and third parties, all with positive conclusions and stating GCP compliance and 18 GCP inspections – Netherlands (1) and Romania (6). All inspections concluded, also, with GCP compliance and data acceptance. If you need more than a CRO for clinical monitoring and auditing of your studies, get in touch now with our team!

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VALIDATION AND ACCREDITATION

International certified expertise

3S Pharma is a full-service Contract Research Organization (CRO) with internationally recognized capabilities in clinical pharmacology and bioanalysis.

The company operates state-of-the-art clinical research units in Romania and Moldova, which have been successfully inspected by regulatory authorities such as the U.S. Food and Drug Administration (FDA), as well as national agencies from France (ANSM), The Netherlands (CCMO), Germany (BfArM), Austria (AGES), Denmark (DKMA), and Romania (ANMDMR), often under the coordination of the European Medicines Agency (EMA).
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These inspections confirm 3S Pharma’s full compliance with ICH-GCP guidelines and international regulatory requirements.

The organization’s extensive operational portfolio—comprising over 1,000 registered clinical trials globally—and its contribution to scientific literature further validate its role as a reliable and competent CRO partner for early-phase and late-phase development programs.

3 S Pharma ensures end-to-end solutions and support and continues to shape new approaches under international regulatory guidance.

Nevertheless, our researchers outstanding performance is also highlighted by a series of relevant publications in international peer reviewed journals and by the participation in public research projects in cooperation with other institutions (Universities, National Research Centers).
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