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CLINICAL TRIALS
MANAGEMENT

CLINICAL TRIALS MANAGEMENT

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.

PROVEN FORMULA FOR SUCCESS

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.

  • Plan and execute critical milestones for every study
  • Coordinate proactive communication between all parties: investigators, IECs, Ministry of Health officials and sponsors
  • Oversee all team members’ day-day activities
  • Identify and execute processes to improve data quality

We provide tailor-made monitoring plans that fit your trial, including remote 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.

ANY SIZE. ANY FOCUS.
ANY CONFIGURATION.

GCP is flexible and agile to meet the dynamic needs of the drug and medical device clinical trials. That means we can handle any size project and meet your unique needs. In all therapeutic areas. We conform and adapt to your needs.

LOCAL WITH A GLOBAL REACH

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 conduct 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.

PROVEN TRACK RECORD

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.

Clinical Trials Management Services

We offer a wide range of services customized to meet the demands of any size project

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Protocol
development
Document

 

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.

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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.

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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.

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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.

Document Management

 

Electronic Trial Master File (TMF) 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

INVESTED IN YOUR SUCCESS

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.

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Therapeutic expertise

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

Drug Trials by
Therapeutic Area

  • Oncology
  • Cardiovascular
  • Anti-Infective
  • Neurosciences
  • Metabolic
  • Immunology
  • Other
  • Respiratory
  • Women's Health
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MEDICAL DEVICE EXPERTISE

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.

Medical Device Trials by
Therapeutic Area

  • Cardiovascular
  • Metabolic
  • Oncology
  • Dental
  • Cannabis
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