Services


  • Study feasibility


We offer our clients complex feasibility analysis, which can be performed in Poland, Czech Republic, Slovakia and in other CEE countries. Thanks to a modern reference system, we are able to select in a very short time both sites & Investigators meeting all requirements of respective clinical trial. Sites selected by us always possess all needed equipment and facilities to conduct the trial in a proper way. We always co-operate with Investigators, who have at least few years experience in conducting clinical trials. We selects sites & Investigators, with verified quality (known from our own experience, recommended by other CROs or Sponsors).

 

  • Site & Investigators contracts negotiations

 

Our experienced personnel prepares the body of each contract's type and negotiates all the terms & conditions with site lawyers & Investigators. Nowadays, negotiations process is very time-consuming, but thanks to experience & law aspects knowledge of our professional team, we are able to reach a consensus quite promptly and organize signing the contracts by respective parties.

 

  • Clinical Trial registration process

 

Our regulatory specialists prepare complete trial documentation needed for submissions to respective Competent Authorities, such as Regulatory Authority & Ethics Committee/Insitutional Review Board (EC/IRB). It is very important to prepare all submission documents in a proper way, to avoid any kind of administrative requests. Receiving positive EC/IRB opinion & Regulatory Authority approval is a long-term process and any kind of error or mistake makes it even longer and causes delay in initiating clinical trial. Long-term co-operation between our regulatory specialists and respective authorities, allow us to avoid any kind of misunderstandings and make this process as short as possible.

 

  • Monitoring of phase II - IV Clinical Trials

 

Brillance employs a team of experienced and qualified Clinical Operations Managers, Senior Clincal Research Associates and Clinical Research Associates based in Poland, Czech Republic and Slovakia. We offer a wide range of complex phase II – IV clinical trials management & monitoring services, including site management services for our customers. We perform our monitoring services according to Brillance SOPs or SOPs of our customers depending on their needs. Our professional personnel has a medical background & education.


  • Personnel leasing – contract hire

 

Personnel leasing is a contract hire service offered for companies, that are not interested in permanent employment of staff on their own. This kind of service concerns contract hire of one of Brillance's employees such as Clinical Trial Administrator, CRA, SCRA or other in order to work in customer's company temporarily. It is possible to deliver the staff to a customer for indefinite time hire or only for specific projects/tasks.

 

  • Personnel recruitment services for third parties

 

This offer is addressed to our customers interested in contracting Brillance for specific recruitment process for positions connected with medical, pharmaceutical, biotechnology or clinical research industry. All candidates are recruited in the way of comprehensive Assessment Centre and after final approval by a customer, they start their job for our client as an independent customer's employees.


  • Data Management services

 

We offer our clients wide range of clinical trials data management services, such as: database programming, double data entry, data cleaning, classification of AE, classification of concomitant diseases, statistical plan, statistical analysis and programming, statistical report writing and preparation of final presentation.