Site Management

SMO-Pharmina ensures relevant protocol adherence and GCP compliance of clinical trial sites, quicker start-up times, rapid recruitment of patients, accurate documentation and reduced study time frames.

During its 11 years of experience, SMO-Pharmina has contributed to the establishment of GCP-compliant clinics. Nowadays, our partners are clinical trial sites in all therapeutic areas. According to Sponsor and protocol requirements, SMO selects GCP-compliant sites which can provide appropriate patient recruitment and management. Read more: Partner Clinics

We ensure the management of entire projects from start-up to close-out: Speedy contract negotiation, budget planning, preparation of regulatory documentation and site activation planning, which includes training of study staff according to GCP standards and trial-specific procedures. Regular internal monitoring ensures data accuracy and minimizes any type of deviation, making it easy for the study team and sponsor to collaborate. Read more: Project Management

All of SMO-Pharmina’s coordinators are medical doctors, have experience in different phases of clinical trials and are fluent in English. Read More: Study Coordinators

SMO-Pharmina ensures contract negotiations with sites in a highly effective and timely manner.  SMO-Pharmina ensures compliance with local and international regulations.

SMO provides Sponsors/CROs with an appropriate budget according to the protocol. SMO conducts budget negotiations with sites in a highly effective and timely manner.

SMO makes the payment process easier for CROs and Sponsors by accurately invoicing relevant expensing, calculating site fees and processing payments in line with local tax requirements.

SMO-Pharmina supervises patient recruitment rate at clinical trial sites, and if necessary offers sites a wide network of referral clinics and doctors.

We support clinical trial sites to work correctly according to local regulations and GCP, and offer advice on the creation and working processes of local ethics committees.

SMO-Pharmina provides clinical trial sites with medical supplies, as well as the technical equipment required for the clinical trials, and helps sites copmly with technical and metrologic standards.

If needed, SMO-Pharmina can arrange the procurement and distribution of any necessary medications or materials to clinical trial sites.

 

We provide receipt, storage and distribution of Investigational products and other clinical trial materials to clinical trial sites under temperature-controlled conditions, as well as their return from sites and/or destruction according to company SOPs, Sponsor and RA requirements, and GSP and GDP standards. Read more: Pharmaceutical Warehouse

Our organization ensures the safety of pharmaceutical products at every stage of distribution according to local SOPs, Sponsor and Regulatory requirements, and Good Distribution Practice (GDP). Read More: Transportation Services

Our laboratory is equipped with up-to-date diagnostic equipment used for variety of hematological, biochemical, immunological and coagulation tests. The Laboratory is enrolled in external and interlaboratory quality control schemes, and performs internal quality control monitoring on a daily basis. Read more: Clinical Laboratory

If necessary, SMO-Pharmina can provide trial sites with archive support and store trial documentation for a certain period of time according to local SOPs, Sponsor and RA requirements.

SMO partners with certified translators and offers translation and notarial approval services for all the medical/non-medical documentation required for the study.