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Risk Management in the Pharmaceutical Industry: Automate the Clinical Trial COI Process

For pharmaceutical companies large and small, obtaining a certificate of insurance means piles of paperwork and the potential for clinical trial delay. Automating the process helps clinical trials get underway faster, and without gaps in coverage.  

Clinical trials are at the heart of the discovery and development of new drugs and treatment modalities. They create a pathway for determining the safety and efficacy of what’s next in patient care.

And yet, clinical trials take time. In fact, it takes on average 10 years for a new medicine to come to market, with each drug costing an estimated $2.6 billion.[1] This number, of course, incorporates thousands and sometimes millions of R&D dead ends as well.

That’s why when a pharmaceutical company is ready to roll out a clinical trial, they want it to commence as soon as possible. Delays at the beginning of the process can be costly and threaten to derail momentum necessary to attracting volunteers and critical funding.

One of the most common clinical trial delays is the issuance of certificates of insurance (COI).


Understanding the COI processes and its challenges

Any delay to the clinical trials process can have a real effect on the new drug or treatment modality’s speed to market. Timely and accurate provision of COIs is therefore critical to innovation. Three factors are commonly known to delay the COI process:

  • Data: Clinical trial and risk data needs to be collected by the pharmaceutical company and exchanged between the broker and underwriter to inform the COI process. The amount of data required by the insurance carriers has grown significantly in the last few years as risks have mounted.

  • International scope: Difficulties in patient recruitment have led many pharmaceutical companies to expand the scope of their clinical trials internationally. This opens the clinical trial up to additional risk management exposures. It’s critical to partner with insurance companies and risk management solutions with a global network of affiliates and partnerships.

  • Regulations: Ever increasing regulatory requirements means a COI must be compliant with every local jurisdiction a clinical trial operates in internationally, as each have their own data and insurance requirements.

5 Considerations for an efficient and speedy COI process

To prevent the above challenges from delaying the issuance of a COI, determine the following five insurance parameters as they relate to a clinical trial.

  1. Compliance requirements and deadlines. International clinical trials taking place in multiple jurisdictions will likely warrant a unique set of country-specific certificate templates, each with electronic signatures. Knowing these deadlines and what each jurisdiction requires is critical to obtaining each COI. 

  2. No-fault policy. Some territories will require a separate no-fault policy, as opposed to a General Liability extension, often written in the local language. Determine ahead of time if a no-fault policy is necessary for your clinical trial, and which locations require it.

  3. Locally licensed underwriter. Similarly, a jurisdiction may require insurance coverage to be placed with a locally licensed insurer, rather than a multi-national underwriter. Knowing the rule on the ground will be critical to obtaining the COI on time.

  4. Insurance limits. Know each country will have their own requirement for limits of insurance. Find out what they are and be prepared.

  5. Policy period requirements. Some countries will require an insurance policy period to span the duration of the clinical trial, and potentially even beyond, especially when the trial includes children. Others may simply require a traditional 12-month policy period.

Coordinating this information and more can be extremely difficult. For small pharmaceutical companies without vast experience or the personnel necessary to do the leg work, the COI process can be very labor intensive and challenging. For large pharmaceutical companies with hundreds of clinical trials at play across the world, the COI process could consume an entire team around the clock.

Alternatively, adopting modern technology can automate COI issuance and support best practices in risk management in the pharmaceutical industry.


Reduce clinical trial delays with the right risk management software

Even when a pharmaceutical company understands the requirements of each jurisdiction, collects the right documentation and participates in the necessary paperwork exchange, the COI process can be daunting. That’s where automation comes in.

Automating the COI process means building redundancies into the process to both reduce the amount of time required to successfully produce the COI and avoiding costly delays and unnecessary gaps in coverage.

Here’s what pharmaceutical companies looking to automate COIs should seek in risk management software:

  1. A simple and intuitive portal. An online system with a simplified and intuitive interface will help guide users through the COI process. A dashboard should allow teams across locations to work together in the system.

  2. Capable of saving and populating basic information for each certificate. This function will ensure information about the clinical trial and the company’s contact information, etc., is only entered once, and then populated into each COI automatically, saving significant time and eliminating common mistakes.

  3. Automatic collation of information. Information should be able to be collated from various parties and other clinical trials to automatically generate each COI.

  4. Ability to automatically save all documents and correspondence. When referring back to a previous COI for a clinical trial, this can save time and eliminate the need to manually save and categorize documents and correspondence. This also provides an audit trail and the ability to generate management reports.

  5. Country-specific templates available. With country-specific COI templates, the process of downloading and filling out forms is simplified and consistent.


Next Steps

If your pharmaceutical company is still facing costly delays in getting your human clinical trials up and running due to failure to secure certificates of insurance in a timely manner, consider how automating your manual processing can help.

For more information on risk management in the pharmaceutical industry, check out this case study or contact Hunter Welch, our Pharmaceutical practice leader.




Feb 19, 2021

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