CRO Services

TechnoSTAT provides a full set of cutting-edge CRO expertise and services to the pharmaceutical, biotechnology, and medical device industries for both local and international sponsors. Our services comply with GCP guidelines, and applicable local regulations.

TechnoSTAT has established links with physician networks, key opinion leaders, government bodies and patient groups, both within Israel and abroad. Our acquired professional experience assist our clients in understanding market access, clinical study requirements and study planning. We also provide regulatory expertise and access to scientific advice, all of which ensures optimal design for your clinical program.

Our flexible, creative approach is designed to meet every client’s needs.

Our experienced CRAs appreciate the need for a creative approach to subject recruitment and for painstaking follow-up once the trial is underway. TechnoSTAT’s CRO will ensure that your clinical trial will proceed as smoothly as possible, yielding reliable and valid data.

Our CRO services include the following:

  • Site identification and feasibility assessment
  • Submission of application to local and national ethics committees (e.g. IRBs)
  • Planning and execution of investigators meetings
  • Pre-study visits
  • Initiation visits
  • Interim monitoring visits
  • Close out visits
  • Assistance in import of investigational product/device
  • Investigational medicinal product /medical device storage and accountability
  • Informed consent form (ICF) translations
  • Medical writing: Protocols, CRFs, monitoring plans and more
  • Handling and resolution of AEs and SAEs
  • CRF development—whether electronic or paper
  • Investigational product/device labeling
  • Clinical project management
  • Maintaining close contact with the site team
  • Prepare for site audit/inspection
  • Recruitment enhancement activities and support
  • Production and maintenance of essential study documents
  • Execute clinical trial agreements/contracts

Our CRO also provides project management services, including:

  • Recognizing, maintaining and coordinating outlines, budgets and resources
  • Supervision of full implementation of contracts
  • Identifying and adhering to critical objectives and milestones throughout the trial
  • Evaluating risk factors and offering suitable substitutes
  • Assessing study progress and coordinating the relevant teams

At TechnoSTAT, we understand the special needs and challenges facing small and medium-sized companies with respect to quality, timelines and costs. We have thus designed pricing and activity models specifically tailored to such organizations’ requirements.