The clinical trial services

IRM Clinical Trial Services are developed to support key industry stakeholders: Sponsors, CROs, Sites as well as global Functional Service Providers to deliver a successful Clinical Trial. IRM Clinical Trial Services are focused on:

Recruitment and Retention

The clinical trial services

Recruitment and Retention

While the number of clinical trials in Ukraine increasing and their efficiency and quality as well, patient recruitment and retention becomes more crucial.
The success of the trial depends on identifying the right patients for the study and their further engagement to invest their time and effort into drug development. Patient recruitment is considered to be one of the most difficult challenges and it is estimated that 80% of clinical trials do not meet their patient enrolment deadlines.
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Besides, retaining patients is also a matter of concern, considering that the approximate dropout rate across clinical studies is around 30%. While the reasons for patient dropouts can vary and are often due to uncontrollable circumstances, in a lot of cases, dropouts can be predicted and thus prevented.

The above-mentioned challenges have led key players in the pharmaceutical industry to seek external support of specialized companies to expedite the patient recruitment and optimize patient retention processes.
We have developed multiple strategies to enhance patient recruitment and optimize patient retention in clinical trials using a patient-centered approach. A set of patient concierge services complements the service offering allowing easing the burden on patients and their caregivers during clinical trials as well as optimizes administration efforts of site staff.

Our Services

  • Patient Travel and Transportation Services
  • Expense Reimbursement
  • Set-up of Referral Networks

Recruiting can be a long and hard-working process, but having a deal with IRM, you will experience how a good plan for optimizing your recruitment efforts can be beneficial from both the cost and time saving. With our dedicated team responsible for the Recruitment and Retention programs, you can be sure that your study will enroll and retain patients well.

About Patient Travel and Transportation Services

Safe, prompt and reliable organization of patients travel to the site and back will expedite patients retention in your clinical trials, increase compliance with visit schedule and reduce workload of study coordinators.
IRM travel coordinators will organize and support any type of transfer. Options include but not limited to dedicated transfers by car, ambulance charter, rail and air means of transport.
IRM network of transportation providers covers all regions of Ukraine and includes at least 2 providers per region to ensure undisrupted provision of service. IRM has developed procedures for quality and operational oversight and constantly monitors the metrics.

Key features:

  • Nationwide coverage
  • All means of transport
  • Regular or Ambulance
  • City Transfers
  • Regional Transfers
  • Back-ups for undisrupted service
  • 24/7 Service

About Expense Reimbursement

IRM provides legal and transparent Expense Reimbursement options in the form vouchers, certificates or other services.

Reimbursement may cover:

  • Travel expenses
  • Accommodation
  • Loss of income
  • Meals

Expense Reimbursement Services are designed to meet legislation of Ukraine and EU Clinical Trial Directive (2001/20/EC) and Regulation (536/2014) that states: no incentives or financial inducements are given to incapacitated participants or minors (or either of their legally designated representatives), or to pregnant women, except for compensation for expenses and loss of earnings directly related to participation in the clinical trial.

We also request that any compensation is reviewed and approved by the respective Ethics Committee.

About Referral Networks

IRM nationwide network of healthcare professionals allows optimizing and enhancing patient enrollment.
Incorporated Physician Referral Network allows clinical trial sites offset the time and effort required to identify and refer patients for enrollment in clinical trials at centers outside their own. Referral Networks also allow substantially increase patient catchment area.
IRM supports identification of referral physician, developing of key messages about the Study and performs trainings on the eligibility criteria so they the right patients are referred.

Equipment and ancillary materials sourcing

The clinical trial services

Equipment and ancillary materials sourcing

IRM is a reliable partner for clinical trial equipment and ancillary materials sourcing in Ukraine providing end-to-end supply chain management with procurement and rental options.
No matter the study size is, IRM is able to supply all the necessary equipment and ancillary materials to clinical trial sites prior study start as well as to maintain the equipment and required stock level of ancillary materials throughout study conduct.

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Clinical Trial Equipment we offer:

  • ECG devices
  • Meters & Monitors (Blood Pressure Monitors, Pulse Oximeters, Thermometers)
  • Spirometry equipment
  • Standard and Refrigerated Centrifuges
  • 2-8°C, -20°C, -80°C refrigerators and freezer
  • Infusion pumps
  • Temperature monitoring devices (min/max thermometers, data loggers)
  • Laptops, tablets, smartphones

Ancillary Materials we offer:

  • ECG paper
  • IV lines
  • Disposables (any kind)

Supply Chain Management Services we provide:

  • Importer of Record
  • Customs Clearance
  • Equipment certification and calibration
  • Annual service and re-calibration
  • Storage and Distribution (including White Glove Delivery)
  • Equipment installation at the sites and site user training
  • Supplies tracking and inventory control
  • Expiry dates tracking and reporting
  • Returns and Destruction (Recycle) Management.
Download IRM Equipment Catalog

Investigators Meetings

The clinical trial services

Effective investigator meeting is an important part of every clinical trial allowing transforming individual healthcare professionals into a coherent study team. Everyone needs to be on the same page regarding the clinical trial's purpose, protocols, participant enrollment criteria, safety issues, and more. When onboarding IRM, you will be able to create an experience that leaves site staff well trained, motivated, ready to enroll patients, and able to effectively solve problems that may arise. If you're looking for ways to increase engagement and drive true value from your meetings, please do not hesitate to contact us.

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Services we offer:

  • Event Management
  • Venue Finding & Set-up
  • Production & Logistics
  • Travel Management

We offer live, virtual or hybrid events with accommodation of customer’s requirements or policies to meeting, travel, privacy and data protection.
What is more, our flexibility and transparent accountancy will benefit you in a cost-effectiveness while we can suggest many options with an adequate location and venue to avoid unexpected and irrational expenses to meet your budget requirement.

eTMF Management

The clinical trial services

The Trial Master File (TMF), the essence of every clinical trial, supports the quality, integrity, and validity of the collected data. With TMF contributors positioned around the globe, there is an obvious need for Clinical Trial Sponsors to look at their eTMF management processes to ensure timely TMF completeness, required quality of documents and inspection readiness of the file.

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Multiple service providers typically contribute TMF and it is challenging to ensure high quality and inspection readiness of the TMF across all studies. Also usage of several eTMF management systems may increase the Sponsor’s burden to oversee the status.
IRM allows you to streamline the TMF management process providing the Clinical Trial Sponsor with dedicated, sponsor-focused team for eTMF management process.
Acting on Sponsor’s behalf IRM supports:

  • eTMF selection and implementation
  • eTMF Management SOP development
  • Document Quality-Check, Filing and Indexing
  • eTMF Audits

Utilizing Sponsor-selected eTMF platform, IRM dedicated TMF management team will process timely QC, filing and indexing of incoming documents in the eTMF to ensure real-time inspection readiness.

Contact us to receive more details!