Sintesi Research S.r.l.

Sintesi Research S.r.l. is a privately held, full-service Contract Research Organization (CRO) headquartered in Milan, Italy. Founded in 2005, the company positions itself as an international CRO delivering clinical research "on time, on budget" for biotechnology and pharmaceutical companies, as well as for sponsors of medical device, advanced therapy, nutraceutical, and observational studies. Its stated mission is to accelerate and improve the development of therapeutic products, medical devices, and related products. The firm operates as a partner across the entire clinical development spectrum. Its service portfolio spans study design, feasibility, regulatory affairs, clinical monitoring, electronic archiving, project management, data management, statistics, medical writing, laboratory management, meeting organization, supply management, dedicated project websites, safety management, product distribution, patient support programs, and medical affairs. Sintesi Research emphasizes customized, tailored solutions rather than a one-size-fits-all approach, and it supports clients either with complete clinical programs from study design to clinical study report (CSR) or with specific individual tasks within their trials. Sintesi Research's therapeutic and product expertise covers all phases of drug-related trials across several therapeutic areas, with particular focus on ethical products, medical devices, advanced therapies, no-profit Investigator Initiated Trials (IITs), and epidemiologic/observational research. The company also manages clinical trials for nutraceutical studies and compassionate use programs. Its operational staff includes medical writers, regulatory experts, project managers, clinical monitors, data managers, statisticians, safety officers, and quality assurance personnel. Geographically, Sintesi Research maintains its headquarters in Milan, Italy, with additional locations in Barcelona, Spain, and Tel Aviv, Israel. This footprint supports its claim of conducting clinical research activities on a global level. The company is led by CEO Paolo De Simoni. As a private limited company (S.r.l.), it is not publicly listed. Its client base includes national and international biotechnology and pharmaceutical companies, and the company states that it has earned the confidence and trust of these clients through attention to detail and an uncompromising focus on quality.

Sintesi Research S.r.l. was founded in 2005 in Italy as a full-service Contract Research Organization (CRO). From its base in Milan, the company grew into an international CRO serving biotechnology and pharmaceutical clients. Its early positioning centered on providing clinical research services with a strong emphasis on quality, timeliness, and budget adherence, encapsulated in its tagline "On time, On budget." Over the years, Sintesi Research expanded its geographic footprint beyond Italy. It established additional operational locations in Barcelona, Spain, and Tel Aviv, Israel, enabling it to manage multi-country clinical trials and support clients on a global level. The company also broadened its service portfolio to cover the full clinical development path, from study design and feasibility through regulatory submissions, clinical monitoring, data management, statistics, medical writing, and medical affairs. A notable development in its service offering was the introduction of Sidox, a validated electronic platform for Trial Master File (TMF) and Investigator Site File (ISF) management. This platform supports GCP-compliant templates, easy monitoring through checklist functions, and optimized inspection-readiness, reflecting the company's adaptation to the increasing digitalization of clinical trials. Sintesi Research has also adapted to the growing complexity and variety of clinical research. Its expertise now extends beyond traditional drug trials to include medical devices, advanced therapies, nutraceutical studies, no-profit Investigator Initiated Trials (IITs), epidemiologic and observational studies, and compassionate use programs. The company emphasizes customized solutions and has built a multidisciplinary operational team comprising medical writers, regulatory experts, project managers, clinical monitors, data managers, statisticians, safety officers, and quality assurance personnel. Under the leadership of CEO Paolo De Simoni, Sintesi Research continues to operate as a private limited company (S.r.l.) headquartered in Milan. It maintains its focus on partnering with clients to execute clinical projects with attention to detail and an uncompromising focus on quality, which the company states has earned it the confidence and trust of national and international biotechnology and pharmaceutical companies.

• 2005

  Sintesi Research S.r.l. founded in Italy as a full-service Contract Research Organization.

• Established additional locations in Barcelona, Spain, and Tel Aviv, Israel.

• Introduced Sidox, a validated electronic platform for TMF and ISF management.

International Contract Research Organization delivering tailored clinical research solutions on time and on budget, with a focus on quality and client trust.

• Sidox

  A validated platform for Trial Master File (TMF) and Investigator Site File (ISF) electronic archiving, with GCP-compliant templates, checklist monitoring, and inspection-readiness features.

1. 1Sintesi Research official website homepagesintesiresearch.com
2. 2Sintesi Research services pagesintesiresearch.com
3. 3Sintesi Research about us pagesintesiresearch.com
4. 4Wikidata entry for Sintesi Research S.r.l. (Italy)wikidata.org