Our Clinical Trials Division offers a full range of drug and medical device development services to support, facilitate and manage the entire clinical research process, throughout all phases of clinical development and across all major therapeutic areas.
We work closely with every client to properly plan so that timelines are realistic and costs carefully controlled.
The key to obtaining high quality clinical trial results is good planning and management. Our goal is to lead your project so you can focus on your key research and business while leaving the project management to us.
We provide tailor-made monitoring plans that fit your trial, including remote site monitoring or risk-based monitoring. We understand that every aspect of the study must be documented in order to obtain useful data and comply with Good Clinical Practice (GCP) guidelines and regulations. And throughout, we are focused on quality, budget, and timelines because our job: to make sure your clinical trial runs smoothly.
No matter how many countries or sites are involved, GCP can serve as your single global project manager and the primary sponsor contact. Through our international network of partners, we guarantee consistent performance that has no geographic obstacles. Each regional representative brings a seamless local approach to choosing the right investigators, and complying with local regulatory requirements. This is especially important for smaller companies, such as medical device startups. Our network allows us to overcome geographic and cultural gaps in multinational trials, like a global CRO, but offer sponsors the unique advantages of a local, smaller CRO such as lower costs, flexibility, familiarity with local cultural, transparency and local regulatory expertise.
Predictable outcomes, excellent execution. Our customers rely on our leadership and guidance
throughout all phases of your pharma or medical device clinical trials – from First in Human to observational registries.
We offer a wide range of services customized to meet the demands of any size project
Protocol
development
Literature searches, liaise with study physicians and investigators, discussing biostatistics and data management, internal review and more to ensure well-written protocols that detail rationale, objectives, design, methodology, statistical considerations and safety.
Informed Consent Form (ICF) development
Compliant with protocols, ICH-GCP, sponsor’s SOPs, and local regulations.
Study feasibility & Site(s) selection
Our close connections and long-term relationships with trial centers and sites help us choose the site and streamline reliable and high-quality feasibility reviews, keep to timelines.
Regulatory Affairs for EC & Ministry of Health submissions
Effective assessment and strategies to ensure fast project progression, including, IEC and Ministry of Health submissions, and monitoring and response to IEC and Ministry queries.
Project Management
Comprehensive project management from A to Z so you can focus on your research and business. From overseeing timelines, scheduling and task assignments to global studies and managing partner CROs.
eTMF Management
Electronic Trial Master File (eTMF) Management to improve transparency, maintain data integrity and regulatory compliance.
Site Management
Regular, proactive and open communication with all parties at every stage of the study to ensure data quality and smooth operations.
Clinical Monitoring; onsite & remotely
We employ risk-based monitoring (RBM) techniques that guarantee excellent data for more informed decision-making and cleaner interim data.
Sites’ Budgets & Agreements Support
Expedited processes based on a large database of previously negotiated agreements and familiarity with sites’ acceptable parameters.
Medical Monitoring
Rigorous oversight including site training, team training, eligibility, safety and support, SAE review and coding, composing safety narratives, and subject data review to identify trends and risks.
Pharmacovigilance
Case processing and reporting, literature searches, periodic reporting, safety signal detection.
Medical Writing
Translate high-level clinical trial strategy visions into clear and concise documents, protocols and reports, working closely with biostatisticians for a fully integrated final study report
We invest in an in-depth understanding of clients’ needs. All GCP staff and senior management are committed to be available and totally engaged in all aspects of our client’s clinical research. Our teams have been with us for a long time, and we have accumulated over 287 years of personnel experience. that’s how we build relationships based on trust, reliability and mutual respect. It is more than an investment in a specific clinical trial. It is an investment in the success of our clients’ products.
To ensure high quality outcomes, you need a CRO with therapeutic expertise. We deliver crucial
therapeutic insights from experience conducting hundreds of trials in a wide range of medical disciplines.
Oncology And
Hemato-Oncology
Auto Immune
Disorders
Gastroenterology
And Hepatology
Cardiovascular
Respiratory
Metabolic And
Endocrine
Neurosciences
Ophthalmology
Dermatology
Women’s Health
Infectious
Diseases
Pediatrics
Rare
diseases
Cannabis
The regulations for performing clinical studies for data supporting the performance and safety of medical devices are updated constantly. The new Medical Device Regulation (MDR) entered into force on May 26, 2017 and will apply starting May 26, 2020. These regulations, designed to increase medical device safety and effectiveness, will require updating clinical evidence for existing and new devices in order to comply with the new set of regulations. At GCP we are ready to help you planning the needed clinical trial protocol and manage your study to keep you compliant with the requirements of either the EU, the US and/or Israeli regulations.
