SOURCING & PROCUREMENT

Sourcing & Procurement

At Intrinseque Health, the sourcing and procurement of supplies is not as simple as a “buy and ship” process. There are several factors that are taken into account during the development of a strategic clinical supply plan and they vary from country to country.

Intrinseque Health has an extensive network of vetted, qualified and proven manufacturers and suppliers around the world. This enables our team to identify products that are best suited for a given study. Our goal is to ensure not only that the supplies, equipment and services are available at the site on time but also that they operate and are utilized without any issues throughout the lifecycle of the study.

Operational Strategy & Planning (OS&P)

Importance of a robust & pressure-tested clinical supply plan in often under-estimated. The supply plan could add to the success or failure of a clinical study. At Intrinseque, our Operational Strategy & Planning (OS&P) team is assigned to each and every project. This team is responsible for assigning resources and designing a robust & pressure-tested supply plan for the project.

The OS&P team consists of the following experts:

Medical Affairs Representative
Project Management Representative
Regulatory Affairs Representative
Sourcing & Procurement Representative
Proposals Representative
Senior Management

The OS&P team follows the operational methodology that is embedded within Intrinseque Health.

The global medical device, clinical supplies and equipment industry is ever-changing. Several factors can impact availability of selected products for a clinical trials. These factors may range from sale of a product removed by the manufacturer in a country/region to non-availability of stocks of the products. Regulatory scenarios for importation of medical devices and supplies may also change in a country/region. Once the strategic supply plan is in place, the OS&P team continues to monitor the progress of each project on regular basis to ensure that the plan is followed and to handle any unforeseen changes that may be required to the supply plan due to changes in market scenarios.

At Intrinseque, we believe in partnership with our client’s drug/device development programs early engagement with our client’s in their development plans. This enables us to ensure all possible eventualities are taken into account well-ahead study execution and if required, applications for regulatory approvals for importation of products are filed along-with clinical trials conduct applications.

Regulatory Services

Although importation may seem to be an easy and convenient task when dealing with sourcing & procurement of medical devices & supplies, regulatory hurdles are often under-estimated. Each country operates under their own unique import & export regulations, which makes it extremely difficult to move products from one country/region to another.

Since these regulations are subject to change without prior, notice, expert understanding of these regulations is extremely important. At Intrinseque, our team of regulatory officials, not only are experts in dealing with such regulations & guidelines but keep a constant tab on these changes. These officials, operate independently under a dedicated business unit with the organization. However, they are a part of the OS&P, who play a key role in designing of the strategic supply plan for projects.

SOURCING & PROCUREMENT

Sourcing & Procurement

Operational Strategy & Planning (OS&P)

The OS&P team consists of the following experts:

Regulatory Services

Please contact us to discuss how Intrinseque can assist with you with provisioning your Sites with the supplies that they need for a successful study.