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SERVICES & EXPERTISE2019-03-05T16:18:48+00:00

"RGL SERVICES - WE ARE A DYNAMIC, FLEXIBLE CRO OFFERING A FULL RANGE OF HIGH-QUALITY SERVICES TO CONDUCT CLINICAL DEVELOPMENT PROGRAMS BY ADAPTING OUR RESOURCES TO CLIENTS' NEEDS."

LEA SEBAG, PHARMACIST
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PROJECT FEASIBILITY

Delays in site initiation and patient recruitment are the major contributors to all cost overruns in clinical trials, especially when today’s R&D budgets are strictly delimited.

RGL Research offers you to evaluate your clinical trial feasibility within lots of previously identified sites around Israel. We particularly assess recruitment potential, staff skills for clinical trials, adequate site facilities, compliance to GCP and first budget estimation.

In addition, the objective is to implement a strategy that would evaluate and mitigate the risks before incurring unnecessary launching costs and to induce a faster initiation, by decreasing delays in patient’s recruitment.

REGULATORY AFFAIRS

RGL Research pluridisciplinary teams will lead your project in front of Competent Authorities trough all stages of pharmaceutical and medical device product development according to your needs within an adaptive and flexible strategy that fits with product specificities.

Our consulting activities include:

  • Clinical Trials applications for Pharmaceutical Products & Medical Devices
  • Medical writing (study documents & specifics applications forms)
  • Genetics trials (pharmacogenomics & pharmacokinetics)
  • Agency and Local Ethical committee interactions
  • Marketing applications
  • Submissions and Publishing
  • Quality review.

REGULATORY AFFAIRS

RGL Research pluridisciplinary teams will lead your project in front of Competent Authorities trough all stages of pharmaceutical and medical device product development according to your needs within an adaptive and flexible strategy that fits with product specificities.

Our consulting activities include:

  • Clinical Trials applications for Pharmaceutical Products & Medical Devices
  • Medical writing (study documents & specifics applications forms)
  • Genetics trials (pharmacogenomics & pharmacokinetics)
  • Agency and Local Ethical committee interactions
  • Marketing applications
  • Submissions and Publishing
  • Quality review.

FINANCIAL & CONTRACTUAL AFFAIRS

Due of budgetization and legal protection is our clients' second concern after patient’s health, RGL Research legal councils in both local and international law are working in close collaboration with RGL projects managers to offer you the most secure framework and lowest costs on the market.

In the same way, development costs are crucial. This is why RGL Research will use the regulatory environment to give your project the highest chances to gain time and costs.

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LOGISTICS

RGL Research solves potential logistic problems before and during your clinical trial that includes: Labeling, QP release, IMPs, and supplies importation, Placebo manufacturing, central laboratory, questionnaires, and medical tests impressions or study material destruction.

Because Quality is a critical component of a successful logistic structure, RGL is working with reliable local partners, GMP and ICH certified and with strong assets in local territory to ensure the best timelines in problems resolving and shipment delivery.

LOGISTICS

RGL Research solves potential logistic problems before and during your clinical trial that includes: Labeling, QP release, IMPs, and supplies importation, Placebo manufacturing, central laboratory, questionnaires, and medical tests impressions or study material destruction.

Because Quality is a critical component of a successful logistic structure, RGL is working with reliable local partners, GMP and ICH certified and with strong assets in local territory to ensure the best timelines in problems resolving and shipment delivery.

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MONITORING

RGL’s strength lies in the distribution on the territory of its CRAs, which allows access to all majors’ hospitals in the country.

Therefore, RGL Research CRAs have extensive experience in clinical trials, source data verification, reporting, and hospital’s staff management, which rely on long-standing relationships with Physicians, their teams and hospitals’ administrations.

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PHARMACOVIGILANCE / DRUGS SAFETY

Whether in Clinical trials or after product marketing, RGL has a department exclusively dedicated to pharmacovigilance, including both data entry in client’s centralized database, using the MedDRA dictionary and pharmacovigilance that can establish product causal relationship.

Even more, this vigilance can be applied locally but also be part of a wider spectrum gathering all clients’ international cases in several languages.

To summarize, Our PV team will provide a pharmacovigilance watch on your marketed pharmaceutical, cosmetic products, and medical devices, case imputability, PV reporting and cases data collection in the client database.

PHARMACOVIGILANCE / DRUGS SAFETY

Whether in Clinical trials or after product marketing, RGL has a department exclusively dedicated to pharmacovigilance, including both data entry in client’s centralized database, using the MedDRA dictionary and pharmacovigilance that can establish product causal relationship.

Even more, this vigilance can be applied locally but also be part of a wider spectrum gathering all clients’ international cases in several languages.

To summarize, Our PV team will provide a pharmacovigilance watch on your marketed pharmaceutical, cosmetic products, and medical devices, case imputability, PV reporting and cases data collection in the client database.

MEDICAL WRITING

  • Protocols
  • Protocol synopsis
  • Risk management plan
  • Investigator’s brochure
  • CRF
  • SOPs
  • Informed consent forms
  • Synopsis clinical study report
  • Clinical study report
  • Scientific articles
  • All IRB/MOH submission study documents
  • Translation of all study documents in compliance with country regulation (Hebrew, Arabic, Russian and English)
  • Institutional, medical, pharmaceutical, company communication

BIO-STATISTICS AND FINAL REPORT

RGL Research team of highly qualified Biostatisticians supports clients with high-quality statistical services while handling projects and surveys according to regulatory requirement.

Among RGL Research different given services, you would find:

  • development and implementation of statistical methodologies,
  • case report form review
  • Statistical Analysis Plan (SAP)
  • data analysis and reporting
  • clinical development planning
  • randomization schedule creation.

BIO-STATISTICS AND FINAL REPORT

RGL Research team of highly qualified Biostatisticians supports clients with high-quality statistical services while handling projects and surveys according to regulatory requirement.

Among RGL Research different given services, you would find:

  • development and implementation of statistical methodologies,
  • case report form review
  • Statistical Analysis Plan (SAP)
  • data analysis and reporting
  • clinical development planning
  • randomization schedule creation.

STUDY CLOSEOUT

Concerning RGL Research study closeout activities, they are performed to confirm that the site investigator’s study obligations and procedures have been completed, the data collected but also post-study obligations are understood and realized as well.

RGL Research will develop with you a closeout plan as part of the study start-up phase and unscheduled closeout implementation ensuring the following tasks:

  • all study forms correction
  • collection, organization
  • all study files are complete
  • fully signed, up-to-date (or shredded if required)
  • if clinical supplies have been shipped and destroyed.
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