SERVICES

Depending on Sponsor’s needs, we offer a wide range of services:

Project management- local and global clinical trials

  • Project set up and Delivery from Feasibility to Close out visit
  • Risk Management
  • Vendor Management
  • Project coordination

 

Feasibility

Our methodology is focused on effectiveness measured by time to response, motivated number of sites, reliable assessment of potential recruitment population for the study. Local standards of care research.

Feasibility tools support the high quality feasibility data by

  • Selection of sites from our network led by very motivated and committed Investigators allows fast initiation of trial, conduct and closeout
  • Approaching the best Investigators in therapeutic area/field
  • Saving time for complete response to our Client

We provide three models of feasibility data requirements, which fits the best for the specific clinical trial stage:

    • Basic-Basing on best specialists in our Network, we can give a quick, reliable and brief review of the potential of sites to perform the study and estimate of potential enrollment.
    • Full-providing precise, solid data. CROS works very closely with clinical sites to identify issues, risks that might affect recruitment, execution and or patient retention and protocol areas that might affect study execution.
    • High level Feasibility- consultancy experience allows to support and advise Sponsor at the project design level. The following factors need to be analyzed:

 

    • Population
    • Recruitment potential
    • Local standards of treatment
    • Regional and or country specific regulation influencing study registration and conduct, including the timelines
    • Logisitic conditions

 

Sites start up:

  • Sites contracting
  • Sites contracting
  • Sites personel training
  • Site activation

 

Clinical Monitoring:

  • Pre-study, Initiation, Monitoring and Close Out Visits, we can outsource Specialist to perform clinical monitoring visits accordingly with Sponsor’s requirements
  • Remote Monitoring Activities
  • Risk-Based Monitoring

 

Site Management and coordination:

We ensure very close and efficient communication with site and Investigators, sites personal trainings on all study team levels, sites activation, pro active support of study team at the site, outsourcing CROS specialist to the Clinic for ensuring highest quality, Motivational visits at the sites, referral network.

Patient’s recruitment:

  • Study sites coordination
  • Site recruitment
  • Retention Plans

 

Medical Monitoring:

  • Scientific support
  • Medical Data Review
  • Medical trainings
  • Medical expertises

 

Regulatory Affairs:

  • Clinical trial application for IMP and devise studies
  • Management of RA and IEC IRB review and submission process
  • Legal representation services
  • Import and Export requirements expertise
  • Adequate all risk insurance coverage against any losses and damages

 

Trainings and Compliance:

  • CH GCP Investigator site personnel training
  • Development programs for CRAs and CTAs
  • Tailored educational solution for Sponsor
  • Therapeutic Area Trainings

 

Quality Assurance:

  • Site audits
  • Co monitoring visits
  • Audits of trial master files
  • Process audits
  • SOP writing and review

 

Investigators and Monitors Meeting:

Investigator meetings are crucial in the area of clinical trials. It gives opportunities to discuss protocol, regulatory issues, procedures and safety criteria together between the sponsor and the site team such as: principal investigators, coordinators, CRA’s, etc.

Our aim is to promote the polish region on the international area. Clear logistic communication and innovative way of organizing this meetings will be the guarantee of the trial success.

Outsourcing:

Outsourcing is also known as Business Process Outsourcing (BPO). This is the process of hiring another individual or company, to handle business activities for you.

Thanks to our long term experience on the market and database of experienced specialists we are able to provide with a business practice that allows small, medium and large-sized organizations to gain the proper skills and competencies in a short period of time. It means, that “you can develop and grow your business any time you need and any way you need without major investment”.

Clinical trials services Conferences

CROS CRO Sp. z o.o.

ul. 17 Stycznia 39 lok. 313
02-148 Warszawa
info@cros-cro.com
+48 796 197 603