CRO Services

TechnoSTAT Clinical Services provides a full array of clinical support and expertise, including project management and clinical 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 team can support your clinical sites and aid in  effective patient enrollment. Our acquired professional experience assists 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.

TechnoSTAT’s expertise in Data Management ensures the highest quality review of data to meet regulatory requirements.  

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 feasibility: 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
• Preparation for site audit/inspection
• Recruitment enhancement activities and support
• Production and maintenance of essential study documents
• Execution of clinical trial agreements/ contracts

The project manager (PM) is a crucial link between sponsor, investigator/s and the clinical team.

Our CRO also provides project management services, including:

• Effective ethical committee (IRB) submissions.
• Recognizing, maintaining and coordinating outlines, budgets and resources
• Help with selecting the most promising site/s for your study.
• Supervision of full implementation of contracts.
• Identifying and adhering to critical objectives and milestones throughout the trial. Choosing a highly skilled PM for your study will be crucial to the study’s success.
• 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.