Tanya is Vice President of data strategies and solutions at Bioforum. She has vast experience across the industry through her current role at Bioforum, as well as the 14 years she spent with IQVIA (legacy Quintiles). Throughout her career, Tanya has worked with multinational pharmaceutical companies as well as small-to-mid size biotechs and startups.

Tanya du Plessis, Brand Insights Contributor, VP, Data Strategies & Solutions, Bioforum the Data Masters

The unplanned costs and delays associated with protocol amendments are a major source of frustration and concern, given their impact on trial budgets and timelines. And now, with the COVID-19 pandemic, dealing with study amendments has become even more challenging, as clinical trial sponsors and their research partners adapt processes and technologies to keep studies moving forward amid the pandemic in an environment where regulations continue to evolve.

The longer your study runs and the more complex it is, the more likely you are to have a mid-study protocol amendment. But even in a pandemic, it’s important to remember that there are preventive and proactive measures that can be taken to reduce the likelihood and impact of some amendments or, at the very least, minimize disruption and ensure the continued productivity of the study team. The more prepared we are for amendments, the more efficient we can be when implementing them and successful in terms of keeping the clinical trial on track.

It all starts with getting the right people around the table

Having a well-defined data strategy with built-in flexibility can curb the high impact of amendments. However, there is a misperception that aligning with a data strategy from study start is not important and it, therefore, gets deprioritized until data starts coming in. Needless to say, this is the common pitfall and trying to plan amendments at this point leads to a number of challenges which have time and cost implications.

The good news is that a flexible data strategy is actually something that can quite easily be achieved, particularly for startups and smaller companies that can avoid the bureaucracy that slows down larger organizations. Working together, in-house experts and trusted partners (covering internal knowledge gaps) should lay out the short and long-term data goals. In doing so, they can define a flexible data strategy that takes in account the risk areas related to data collection and management from the planning phase. For example, this integrated team can, early on, identify mitigations around these areas and supportive tools/applications that can be used to manage unanticipated changes relatively easily (and that are good for function and cost). The key is striking the right balance between following best practices and thinking outside of the box, all while staying within the agreed upon budgets.

A flexible data strategy should be able to accommodate anticipated amendments or changes (i.e., known risks) as well as unanticipated changes (i.e., unknown risks) with as little impact as possible. However, if the data strategy is retroactive and not embedded in the clinical program from the very start, it’s nearly impossible to avoid the chaos of substantive amendments that lead to significantly longer clinical trial cycle times and higher costs.

While no two organization or studies are the same and a template approach is never realistic or advisable, there are five major pillars of a data strategy and associated considerations for each that should be taken into account when you start writing a protocol for a clinical trial. This will enable the development of a data management strategy that is flexible in that it meets the specific, individual needs of both the clinical study and the sponsor’s short and long-term goals.

Remember, while working through these steps, do not limit your options based on in-house expertise or budget considerations. These are, of course, important, but the first step is to determine the best approach. From there, you can dive into the details of choosing the right partners to support your data strategy development and its management, and, in doing so, significantly reduce painful amendments or their impact.

It is also important to note that having budget constraints does not necessarily mean that a startup or small company has to give up on using the latest technology tools, standardization and/or consistency in clinical trial execution—a topic we will address in an upcoming blog, with a focus on how to:

Determine which services are essential and how to weigh the pros and cons when it comes to making budget decisions

Select the right tools/technologies (wading through the options)

Incorporate more standardization and consistency across all trials or study operations

Is there anything else you would like to hear about?

We’re open to evolving these discussion starters based on your input and would love to hear your thoughts, so please reach out and feel free to share ideas. Our goal is to create a forum for knowledge sharing that specifically addresses the needs of the small biotech and startup community.

Looking forward to continuing the small- and mid-size EmergingBio conversation!

 is vice president of data strategies and solutions at Bioforum the Data Masters. She has vast experience across the industry through her current role at Bioforum, as well as the 14 years she spent with IQVIA (legacy Quintiles). Throughout her career, Tanya has worked with multinational pharmaceutical companies as well as small-to-mid size biotechs and startups. She has led various data management operations and programs, heading numerous innovation teams and spearheading the development of strategies for customized data delivery solutions, focusing on timely, quality data. 

A certified clinical data manager (CCDM, SCDM), Tanya holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State in South Africa. She also has a project management professional certification (PMP, PMI).

Bioforum the Data Masters is a data-focused Contract Research Organization (CRO), supporting clients in the utilization of their clinical data and guaranteeing its integrity and accuracy. Our goal is to consistently improve and innovate data processes to allow for the most efficient data submissions for our clients across the life sciences industry and the patients they serve.

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Welcome back to the Forum for EmergingBio's Outsourcing Decisions!  There is nothing quite like protocol amendments to put the brakes on a clinical trial’s momentum, which is why, in this blog, we are turning our attention to how to face this challenge head on.

Regret Comes Too Late: Getting Ahead of Protocol Amendments

	Welcome to the Forum for EmergingBio's Outsourcing Decisions!

	If you’re reading this post, chances are you work in clinical research and are well aware of the countless challenges that life sciences companies face today. Limited headcount and resources combined with increased pressure to contain costs, accelerate timelines and deliver novel, targeted therapies to market are not new challenges for our industry, but they are intensifying amid the COVID-19 crisis. As the biopharma industry traverses uncharted waters and doubles down on efforts to bring new therapies to market quickly, cost effectively and without affecting quality, the success of strategic partnerships and functional service provider models are more critical than ever before.

	But, how can small biotechs and startups successfully navigate the pathway toward finding an outsourcing partner, particularly in a pandemic? Does being “small” limit your options? How big a role should cost, therapeutic expertise and geographic location play when evaluating potential CRO partners? 

When the stakes are even higher from the get-go 

	The stakes are even higher for small biotechs to get CRO and vendor partnerships right from the outset than for Big Pharma as they simply cannot afford missteps. Avoiding mistakes can be especially difficult for emerging companies that do not have an abundance of in-house expertise and resources available, both for executing clinical trials and for risk management and contingency planning.  

	Unexpected “surprises” can be completely out of a company’s control, such as with how COVID-19 has affected certain trial operations. Current and planned clinical trials with traditional site-centric protocols suddenly cannot operate the way they were designed. Due to the social distancing and travel restrictions associated with the pandemic, for example, access to many clinical trial sites is limited for staff, principal investigators (PIs) and, most significantly, patients. Bigger companies have the advantage of being able to invest the time, resources and budgets into adjusting or rethinking their clinical trial design and data collection strategy to deal with these issues. Small biotechs and startups, however, simply do not have the infrastructure and expertise to mirror how big pharma is managing the crisis-all of which means a different approach is required for smaller companies.

Choosing the partner that’s right for you

	The core competencies CROs have built over the decades to service large pharma don’t always fit the fast-paced, entrepreneurial world of small biotechs and startups. Emerging companies need more flexibility and expertise on how to chart the fastest, most efficient course through clinical trials, mitigate any unnecessary risk of delays or failure, and increase the likelihood of launch-all just to survive long enough to have the chance to get their novel treatments into the hands of patients who need them most.

	If they don’t already outsource, emerging companies must first understand why they are going down this path in the first place and what they are trying to achieve-whether it’s clinical support to help with a study or regulatory work to drive data management. The key is to do your homework upfront. What may work for one small company may not work for another.

	And that’s where building relationships with the right partners who understand how emerging biotechs operate and appreciate the entrepreneurial culture of startups is crucial. CROs or service providers that support small biotechs must strike the right balance between following best practices and thinking outside of the box, while ensuring ongoing communication and to stay within the agreed upon budgets.

	All that said, the challenges that emerging companies face can also be seen as opportunities. They have fewer decisionmakers and are nimbler than larger companies weighed down by bureaucracy. Additionally, across the industry, there’s a perception that having budget constraints means that one has to give up standardization and consistency in clinical trial execution. While each trial has its own set of unique design aspects, the actual data strategy for each study does not have to be unique and there are numerous ways to bring this strategic thinking into a company’s processes and procedures, without incurring costs. And lastly, having a less rigid business environment creates the freedom to explore new ways of doing things, spurring innovation.

	The current environment we find ourselves in with COVID-19 illustrates this point; now, we all must rethink the way we’re conducting clinical trials. Indeed, the recent 

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

 entities conducting clinical trials, no matter the size or experience of the organization.

	Over the next few months, as we tackle the coronavirus outbreak and its fallout together as a community, we’ll be discussing all of these different challenges and opportunities in bimonthly blogs on 

		When to outsource and how to choose the right partners

		Identifying the right balance of oversight when working with a service provider and whether internal staffing investments are necessary

		How to incorporate more standardization and consistency across all trials or study operations

		Determining which services are essential and how to weigh the pros and cons when it comes to making budget decisions

What topics would you like to hear about?

	We’re open to evolving these discussion starters based on your input and would love to hear your thoughts, so please reach out and feel free to share ideas. Our goal is to create a forum for knowledge sharing that specifically addresses the needs of the small biotech and startup community.

	Looking forward to continuing the EmergingBio conversation soon!

	Tanya du Plessis	VP, Data Strategies and Solutions 	Bioforum the Data Masters	

As the biopharma industry traverses unchartered waters amid the COVID-19 crisis and doubles down on its efforts to bring new therapies to market faster, cheaper and without affecting quality, the success of strategic partnerships and functional service provider models will become more critical than ever before.

Author | Tanya du Plessis, Brand Insights Contributor, VP, Data Strategies & Solutions, Bioforum the Data Masters

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