Our Clinical Trial Solutions

CliN-M understands that the clinical supply chain is a necessary and critical factor in ensuring a successful study, which is why we are committed to offering our clients fully integrated Clinical management services for their trials to ensure accuracy and efficiency during each stage of the clinical trial supply chain process, by providing you with a blend of credible, unique, and traditional services which makes the trial both time and cost-efficient.

What We Do

  • Storage services
  • Distribution Services
  • Labeling and Packaging Services
  • Returns and Reconciliation services
  • Destruction Services
  • Comparator drug and Ancillary supplies Sourcing
  • Regulatory Services

Clinical Trial Storage

World-class cold chain expertise and capabilities for temperature sensitive products

CliN-M offers a wide variety of clinical storage and distribution solutions to meet all clinical trial’s pharmaceutical needs. We realize the wide range of clinical trial storage capabilities you will need throughout the life cycle of your study, this is why our storage facilities and storage systems are GxP-compliant and offer a variety of controlled environmental conditions to accommodate your clinical trial requirements. Our ambient and cold chain storage rooms are monitored using our fully automated system. We have a 24/7 environmental monitoring system which allows us to monitor temperature and relative humidity, security system as well as controlled access throughout our facilities.
CliN-M offers a variety of controlled environmental conditions to accommodate clinical trial requirements.

  • Controlled Ambient and Relative Humidity (15° to 25°C)
  • Walk-in Controlled Refrigerator (2° to 8°C)
  • Freezing storage (up to -20°C)
  • Dry Storage (Below 35°C)

Clinical Trial Distribution

Complete & proven world-class support for your clinical supply chain strategy.

CliN-M ensures the safe delivery of your temperature-controlled clinical products by effectively accommodating a good range of environmental conditions to guard your test materials.
Along with proficient monitoring and tracking resources, we optimize every level of the cold chain process to confirm the protection of your materials.
We have a highly qualified network of approved regional partners to support regional trial storage, shipping, and distribution processes to supply our clients with the foremost time-efficient and accurate clinical trial logistics solutions. Our logistics experts carefully consider your project dynamics to pick out the optimal mixture of couriers and shipping lanes needed to keep up product integrity while balancing distribution speed and cost-efficiency.
In Egypt, our shipping services cover the whole country (Cairo, Alex, Delta & Upper Egypt).

Our clinical supply chain consultants are highly experienced logistics professionals who are able to support the management of your clinical supply chain by providing:

  • Temperature-Controlled Trucks
  • Shippers:
    • Pallet-Sized Temperature-Controlled Shippers
    • Validated Re-Usable Shippers
    • Dry Ice (-70°C) or Gel Pack Shippers (2-8°)
  •  Data Loggers:
    • Designed, located, and maintained to a customary that suits its intended purpose.
    • Calibrated at defined intervals supported a risk and reliability assessment, including alarms when excursions from predefined storage conditions.
    • Repair, maintenance, and calibration exercises
    • Records and data, in paper and in electronic form.

Clinical Trial Labeling & Packaging

Overcome project challenges and ensure you get the highest quality, most cost-effective solution.

CliN-M strives to offer tailored solutions that streamline the process. CliN.M offers both Ambient and cold labeling and packaging. We are experts at storing, packaging, and labeling, we strive to offer tailored solutions that save you time and give you flexibility if your packaging and labeling needs change suddenly. By performing both Ambient and cold labeling process and provide our clients with innovative, flexible service options for their clinical trials.

CliN-M provides a responsive approach to labeling customization that streamlines the packaging process and is more cost-effective for our clients.

We ensure the highest level of accuracy, with meticulous inspection and QC oversight with our separate temperature-controlled labeling and package area.
Our highly skilled team will consistently be by your side to adhere to your exact protocol needs. By providing customizable solutions that benefit the unique characteristics of your clinical labeling and production needs.

We make sure your pharmaceutical supplies are correctly labeled and produced in a fast, efficient, and timely manner, tailored to your specific trial needs:

  • Label and package design
  • Kit Assembly
  • Expiry update
  • Randomization application
  • Secondary packaging
  • Printing services.
  • Label/Pack Translation services

Regulatory Services

Providing world-class comprehensive regulatory expertise to meet your organization and study requirements.

It is essential to develop a regulatory strategy plan early in medicine development to identify key challenges that may arise and interact collaboratively with regulatory authorities.

CliN-M’s strategic regulatory services span the full spectrum of activities and technical functions, including regulatory development, licensing, and life-cycle management. We remain current with regional regulatory requirements as they evolve. Our proactive approach and careful counseling ensure that there are no surprises. This will enable you to ensure that plan aligns with the profile and commercialization for the drug.

A) Importation and Exportation

  • Obtaining the health authorities importation license
  • Obtaining the health authorities exportation license
  • Preparation of regulatory documents
  • Regulatory submissions
B) Custom Clearance

  • Custom clearance submissions and approval
  • Clearance of shipments from the customs

Inventory Management System

End-to-end visibility providing real-time monitoring and management.

We have developed a validated online tracking system which enables to:

  • Track of IMP stock
  • Fast access to information & reports
  • Receipt records
  • Dispensing records
  • Return records
  • Inventory records

Comparator Drug & Ancillary Supplies Sourcing

A strategic approach to comparator drug sourcing and ancillary supplies sourcing.

CliN-M takes a strategic approach to comparator sourcing for clinical trial supplies by taking the time to fully understand your requirements broadly and optimize your purchasing strategy for commercial products. We work with sponsors during study design to provide comprehensive market assessments that identify the suitable comparator products, co-medications, and ancillary supplies for clinical trials.
Leverage the depth and breadth of our integrated services, clinical supply management and forecasting and more to create a single-source solution that meets your needs.

Our unmatched capabilities in comparator sourcing include:

  • CliN-M provides a safer and efficient way to secure sourcing needs for comparator products and Ancillary supplies in clinical trials.
  • Has strong access to a regional network of manufacturers, wholesalers and distributors.
  • Smart sourcing strategies that keep clinical trial spend within a budget.
  • A validated IT platform designed for clinical supplies and including web-based inventory monitoring.

Return, Reconciliation & Destruction

KEEPING THE END OF YOUR STUDY IN MIND FROM THE BEGINNING

Choosing the most appropriate system at the start of a clinical study can have a tremendous impact, positively or negatively, on the clinical trial returns process during and at the end of a study. We value our clients and their successes, and as such, innovation and cost-efficiency are crucial when it comes to accounting for your clinical drug returns, reconciliation, and destruction.
CliN-M’s global GxP-depots manage returns from clinical sites, perform the reception and reconciliation of returns and provide destruction by locally approved and qualified destruction vendors.
Our clinical supply experts can help you develop a prudent clinical returns plan that takes into consideration any drug or country-specific challenges that may need special consideration.

  • Returned Drug and Kits Accountability and Management
  • Physical Returns
  • Temperature-Controlled Returns
  • Returns to Inventory
  • Transportation of obsolete IMP from clinical sites to destruction areas.
  • IMP treated by incineration,
  • Safely dispose of generated ash (zero landfills) by introducing it in the bricks manufacturing industry as per the approved standards
  • Certified Destruction of Hazardous and Non-Hazardous Material