By Vincent Santa Maria, President, Bilcare GCS, AmericasFueled by longer life expectancies, new diagnostic technologies, advances in medical equipment, and the fluctuating world economy, the healthcare industry is in a state of evolution. As a result, the efficiency of clinical trials materials (CTM) management services have come under increased scrutiny. CTM partners are major contributors to a drug's success or failure – and, as a result, they significantly influence a company's bottom line. Accurate preparation, adequate blinding of clinical trial material supply and integrity of the cGMP quality process are essential; failure in any of these areas could cause the unblinding and halting of a clinical trial, resulting in the loss of millions of dollars worth of clinical data and sales.
Today's clinical trials are global, larger, and more complex than they were in the past. In addition, government regulations are progressively more stringent, requiring a greater number of studies with larger patient populations. By nature, these trials consume more resources on a much larger financial scale than in years past, making pharmaceutical and biotech companies more vulnerable to failures due to poor planning and management.
As a result, closer attention is being paid to CTM services. Do suppliers have the capacity and flexibility to handle the pharmaceutical industry's race to market? Are they utilizing the most up-to-date technologies and equipment? Do they require multiple hand-offs that could increase risks? And, perhaps most importantly, are the services they provide at a level of quality and at a price point that makes continued investment in their services worthwhile?
It turns out that the answer may not just lie with whom you engage as a CTM partner, but with how you engage them.
Multiple Suppliers Multiply Costs
In the past, sourcing from several qualified providers (the so-called "best-of-breed strategy") – a preferred solution in the commodities and manufacturing materials sector – was believed to have yielded benefits to pharmaceutical companies' bottom lines. The theory was that multiple providers ensured cost-competitive bidding and helped risk-conscious procurement specialists guarantee that materials are always available.
Trial and error have proved, however, that engaging multiple CTM providers for segment-specific clinical trial operations complicates the drug development process with duplicate or conflicting procedures, increased administrative burden, increased complexity and, thus, longer timelines. These complications translate to higher costs in terms of administration and lost time to market. The successful, cost-effective outsourcing of clinical trial supplies relies heavily on a vendor's ability to manage the entire clinical supply chain. Identifying a single-source provider with "cradle-to-grave" expertise gives procurement teams a significant advantage.
The Single-Source Advantage
On its most basic operational level, multi-sourcing increases the "soft" or "hidden" costs of purchasing.
Pharmaceutical and biotech companies often mistakenly regard these costs as insignificant. However, they multiply with each vendor for a surprisingly high cumulative effect. Coupled with the administrative costs of product development and clinical trial execution, "hidden costs" are critical factors in considering a single-source provider.
Opting to use a single clinical trial supplies provider simplifies and streamlines outsourcing by:
* Limiting complexity;
* Increasing operational efficiencies;
* Producing personalized support;
* Maximizing knowledge base within the provider;
* Reducing fixed operational costs;
* Improving on-time performance; and
* Shortening time to market.
In a strategic partnership, the goal is to jointly develop solutions in high-value areas. The relationship is interactive (two-way) and involves shared risk and reward. Planning, establishing metrics, continuous improvement and cost reduction are all shared responsibilities.
Hallmarks of a Strategic Alliance
High-yield strategic partnerships can be defined by the value they add to the sponsor's process and should include all of the following qualities. Governance Structure: Both parties must know who will be involved and what their respective roles will be. In clinical trials, the vendor's team typically comprises at least one senior manager, project manager(s), and members from finance and operations. All aspects of the relationship's composition must be clearly defined in writing to ensure mutual agreement and understanding in advance of any action. This includes all functional and reporting parameters and role responsibilities.
Proactive Communication Plan: Reporting and information transfer require a proactive approach that includes scheduled interaction, in writing and in person, as well as methods for quickly addressing unanticipated developments. Since many differences exist in the study types, each plan should be tailored specifically to the study type in question in order to ensure favorable outcomes.
A monthly dashboard allows sponsors to gather snapshot information that may spur proactive corrective action or process modifications. The dashboard should include on-time production, on-time shipment and logistics, and overview reporting of clinical results.
Operational Definitions: Joint creation of itemized descriptions for all operational functions must include:
* Metrics
* Deliverables
* Quality
* Issues
* Resources
* Forecasting
* Financing
* Innovation
Identifying a Target Partner
A strategic partner should be an extension of the sponsor's R&D team, and therefore must be able to pass the same level of scrutiny as the sponsor's own operation. Thus, vetting clinical trial supplies outsourcing providers to find a strategic partner should be a process that encompasses the full range of supply chain factors that are involved in the clinical trial's life cycle.
The ideal partner will be able to manage your needs throughout the clinical trial, regardless of its location and complexity. If, for example, your organization performs (or plans to perform) its trials globally, your vendor must also operate internationally. If your work includes biologically active materials, your vendor must provide cold- or frozen-chain distribution. The second level of evaluation would assess service, capacity and expertise in:
* Formulation development
* Analytical and research services
* Clinical manufacturing
* Comparator sourcing
* Clinical packaging and labeling
* IVRS/IWRS
* QP Services
* In-sourcing and off-site clinical operations
* Logistics, distribution, returns and destruction
* Regulatory compliance for all processes
Global providers should have well-established protocols for international sites and practice with worldwide logistics and documentation.
Experience must be backed by solid technology, including safe data gathering and storage in accordance with cGMP, network stability, and security in compliance with U.S. Federal Title 21, part 11.
Finally, a strategic partner should be as transparent as possible in all of its administration. This includes, but is not limited to, financial and business reporting, regulatory compliance, and administration of the project management team and subcontractors.
As clinical trials grow increasingly global and increasingly complex, it is in sponsors' best interests to simplify administration, reduce opportunities for errors and streamline spending. Using appropriate evaluation tools to select a single, full-service outsourcing provider will help sponsors move their focus from internal management of the clinical supply chain to executing successful clinical trials.
bout the Author Vincent Santa Maria, a veteran of the clinical service industry, has over 25 years of experience primarily in pharmaceutical operations and pharmaceutical services. Prior to joining Bilcare, Santa Maria served as President and Managing Director of Almedica Services Corporation (now Aptuit). Highly regarded throughout the clinical services industry, he brings a wealth of knowledge and experience to Bilcare. Santa Maria is a Certified Public Accountant with a Bachelor of Science degree from Stockton State College in Pomona, New Jersey.