CONTRACT RESEARCH ORGANIZATON CRO GREECE

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CROS&S P.C. is a Contract Research Organization founded by scientists with extensive experience in Clinical and Biomedical Research.

Mission

Our Mission is to provide high quality services, support and solutions to our Clients’ Clinical Development and Medical Affairs.

Our way

Our modus operandi is characterized by focus on quality, constant pursue of excellence in performance, adaptiveness to our clients’ particular needs, commitment to scientific methodology, reliability and business integrity.

Vision

Our vision is to become the most reliable and effective collaborates to our Clients.

In service to the patient

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In service to the patient

Clinical Trials are the “soul” of Clinical Research, the most important and often decisive experiments for the Investigational Products. At CROS&S we value each Investigational Product, not only as the outcome of intelligent, long- lasting, hard, and expensive research, but above all as a potential healthcare solution for those who need it.

As part of the Clinical development process, we work with sense of high responsibility and cherish our contribution to a meaningful cause.

Our Trials

We design, implement and support Clinical Trials in the entire spectrum of the drug clinical development process (Phase I, II, III and IV), and we are experienced in biomarker / translational research related Clinical Trials.

We also provide services, in terms of design and implementation of clinical studies, for the pre market and post market clinical assessment of Medical Devices.

Solutions

Solutions #cros&s

CROS&S core personnel consists of highly educated (M.Sc. or Ph.D.) life-science professionals, with extensive experience in Clinical Trials and medical affairs. We operate according to Good Clinical Practice, following CROS&S or Sponsor’s clinical SOPs.

Medical /Scientific Support

A broad range of Medical and Scientific support is provided to our Clients: preparation of clinical study proposals, design and writing of Trial Protocol, writing of ICF, CRF development, medical material and study documents translation, medical writing of abstracts, presentations, posters and publication manuscripts.

Regulatory Services

CROS&S performs all regulatory procedures required in all stages of a Clinical Trial. During Trial initiation, regulatory services include EudraCT registration, drug labeling, IP/IMP release, contracts preparation and submissions, contracts signing follow up, ISF and TMF preparation, submissions to Sites IRB/IEC and to National Authorities.

During the course of the Trial, we provide TMF maintenance and in case of study amendments negotiations with Insurance vendor, contracts preparation, submissions to Clinical Sites and the National Authorities.

At the end of the Trial, we ensure the preparation of the Completion files and submissions to Trial Sites and the National Authorities

Monitoring

monitoring - contract research organization greece

CROS&S monitoring Team consists of highly educated, extensively trained in clinical studies, GCP/ICH certified personnel, that will ensure compliance to all GCP guidelines and organization policies, perform Qualification Visits, Initiation Visits, Site staff training to trial-specific industry standards, Monitoring visits, source data verification, Close-Out Visits, Drug Accountability and all respective reports.

Data Management

CROS&S supports Clients’ data management needs providing services as: e-CRF construction, operational evaluation and validation, Database design, programming and maintenance, Data Entry, Data cleaning and query management, Data Base Lock, e-CRF end-user training, error evaluation tests, reports and corrective actions.

Statistical Support

A Clinical Trial design requires a reliable statistical design. CROS&S provides sample size calculation and protocol statistics as well as statistical analysis of Trial Data, statistical reports, statistical analysis of survey Data and Market access questionnaires.

Pharmacovigilance

Our PV services include Annual DSUR preparation and Submission, Six-month SUSAR report preparation and submission, Eudravigilance reports and Submissions, Annual Compliance and Audit Safety Meetings, Coding and Management of SAE/SUSAR of clinical studies, Query handling and Communications.

Consultancy Services

At CROS&S we are determined to deliver Support & Solutions to our Clients thus, we provide consultancy over study proposals, Business and Market consultation, advisory over Regulatory Affairs and Medical and Scientific advisory. Moreover, we hire out Medical and Clinical Operations professionals.