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An Introduction to Triad Scientific Solutions

 

 

We all know why we are here.  After years of development, a health or welfare product is ready for commercialization.  The development effort, which likely took multiple years and considerable capital to complete, has resulted in a product that is effective, safe, pure, stable and complaint with relevant quality standards.  However, the fact remains that in order for the product to useful to its user, and to generate revenue for its sponsor, it must undergo the necessary processes of manufacturing, storage and distribution, and delivery.  Unfortunately, each of these necessary and unavoidable processes provides the opportunity for the health or welfare product to interact with the manufacturing equipment, the storage/distribution system, or the delivery device.  As a result of this interaction, substances may be added to or removed from the product, potentially affecting its efficacy, safety, purity, stability and its ability to meet quality standards.  It is therefore necessary to establish that the product, at the point that it is used by the user, remains safe, effective, appropriately pure and compliant.

 

Now we may come together to address these circumstances from a variety of different directions.  We may, in fact, be the owner or sponsor of the product itself.  Alternatively, we may be the supplier of the equipment, systems or devices used in the product’s manufacturing storage, distribution or delivery.  It is possible that we are somewhere in the supply chain, as raw material suppliers to either the product’s sponsor or the equipment, systems or devices suppliers.   We may be regulators, charged with the responsibility of protecting and promoting public health and safety. Or, as is the case with Triad, we may be individuals or organizations which offer services that involve assessing the extent and establishing the effect of the inevitable interactions between the product and the contact items.

 

Regardless of our role, we share the common purpose of establishing that a product is suitable for its intended use, meaning that it is safe, effective, appropriately pure, and of the necessarily quality at its time of use.  Although the industry has evolved to a significant extent in terms of its ability to address the challenge of establishing the suitability of a product for its intended use, the fact remains that meeting this challenge requires a significant, and not inconsequential, effort.  It is a constant challenge to balance the responsibility for insuring product safety, quality, efficacy, purity stability with the investment necessary to provide such assurance.

 

Given the enormity of the challenge of establishing suitability for use, meeting the challenge requires the combined capabilities, facilities, efforts and contributions of a team of scientific, technical and business experts in a number of disciplines involving the physical, chemical, biological and applied sciences.  Triad has established its proper place on this team based on the needs of the sponsors, the roles of the other participants and the capabilities and resources of its own members.   Specifically, Triad is that organization which simplifies and optimizes the complex and extensive process of suitability for use assessment via the practical application of the necessary good science, both in terms of principles and practices.  Based on its long experience with, and broad understanding, of the scientific and practical aspects of suitability for use assessment, Triad helps sponsors, suppliers, vendors, CROs and consultants to devise and implement the right studies at the right time, to produce and assess the right information, to generate the right assessment, and to communicate and defend those studies, information and assessments properly and effectively.  In so doing, Triad helps its partners manage both the science and the budget, recognizing that while it is essential to produce products that are suited for their intended use, it is also necessary to produce such products at the lowest possible cost, as so doing insures that the greatest benefit is realized.

 

More specifically, Triad is positioned to be your valued partner, trusted advisor and preferred provider for the following services related to suitability for use assessment:

           

  • design (and justification thereof), implementation, data review and interpretation, and reporting of experimental studies involving:

    • material, component or system characterization and selection,

    • product/material compatibility (drug binding and degradation),

    • system qualification (extractables),

    • product qualification (leachables.

  • technical and quality review of facilities, processes, practices and personnel.

  • capability and capacity review and assessment.

  • general, focused or customized technical training

  • advocacy and representation for clients during product design, development, registration, commercialization, and marketing.

  • strategic planning of company policies and procedures.

  • vendor qualification and management.

  • analytical method development, optimization, validation and remediation.

  • problem identification, investigation, troubleshooting, resolution and prevention

  • technical writing in preparation of manuscripts, technical documents and submission files or dossiers.

  • wild card opportunities (until you describe the opportunity, how can we know for sure whether we can help or not?)

 

The above services can be provided to support products throughout their life cycle, including development, registration, commercialization and time in market (change control and product retirement).

 

While Triad is not an analytical testing laboratory, it can advise clients in terms of identifying, selecting and managing CROs which share Triad’s passion for good science, practically applied.  Although Triad may not possess all the answers in all the circumstances, it can leverage its extensive network of both chemistry and toxicology experts to ensure that clients have access to highly and appropriately qualified expert partners.         

        

I believe that while an organization may be defined by its mission and vision, its ability to achieve its mission and realize its vision rests squarely on the shoulders of its members.  When that mission and vision involves providing a serve to others, the efficiency and effectiveness with which that serve is provided depends on both the capabilities and principles of the provider’s members.  As the principal and founding member of Triad, it is the largely the case that I am Triad and Triad is me.  For those of you who know me and know my work, that may be recommendation enough; for others, you can get to know me better by reviewing information (such as my vitae, personal statement and list of publications) that is provided elsewhere on Triad’s website.

 

In any event, welcome to Triad, thank you for your interest and I do hope that there is an opportunity for us to work together on our shared mission to enhance, sustain and save lives.