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Successful vendor–sponsor relationships, such as 

those between a contract research organization 

(CRO) and pharmaceutical company, assure and 

accelerate regulatory success for new products. Often, how-

ever, this relationship fails, which delays approval and, in 

turn, costs the pharmaceutical company money by shorten-

ing the market time of the product.

 Demetrius Carter, MBA, 

PMP, RAC-US, shared insight 

on this relationship at the 

AMWA Carolinas 2021 Spring 

Conference by providing meth-

ods of assuring and accelerating 

regulatory success for pharma-

ceutical companies, reasons 

that CRO–pharmaceutical  

company relationships fail,  

successful mitigation strategies, case studies illustrating 

failed relationships, and, finally, techniques to strengthen 

and transform the CRO–pharmaceutical company relation-

ship into a strategic partnership.

 Mr Carter is a clinical development executive with over  

20 years of drug development experience in the pharma-

ceutical and medical device industries. He is the Senior Vice 

President for Regulatory Services at Certara Synchrogenix, 

where he is responsible for their Regulatory Writing, 

Strategy, and Operations teams. His presentation was 

entitled “‘I Can Help You if You Would Just Let Me!’: Best 

Practices in Overcoming a Challenging Sponsor.”1

AMWA: How Can CROs Assure and Accelerate Regulatory 

Success for Pharmaceutical Companies?

Carter: To assure and accelerate regulatory success for 

pharmaceutical companies, 5 key components of the  

CRO’s regulatory process must be fully established and  

supported by the following key CRO personnel and 

advanced technology.

Regulatory and Medical Writing

Writers should be experienced at producing all document 

types for major regulatory agencies by using the Common 

Technical Document (CTD) format. Technologies used by 

writers should drive efficiency and accuracy and speed the 

time to document completion. This should produce high-

quality documents that are properly managed across the 

document development life cycle.

Regulatory Consulting and Regulatory Affairs

There should be a robust drug development strategy to 

guide document development. This should include a clear 

submission strategy directed by effective leadership, a gap 

analysis to detect and provide solutions to inadequacies, 

and expedited pathways to advance urgent documents. This 

should be an integrated global strategy so that content from 

the primary submission can be reused for submission to 

multiple regulatory markets.

Regulatory Operations

The CRO should be an expert at submitting regulatory doc-

uments by using advanced technology that is compliant 

with global health authorities. This expertise should include 

a simplified submission review, proactive management of 

timelines and deliverables, and electronic CTD delivery for 

every therapeutic area.

Regulatory Technology

To save time and resources, the CRO should use advanced 

technology powered by artificial intelligence (AI) to map 

clinical data to templates and automate development of 

documents.

Diana Henzel, PharmD / Freelance Medical Writer, ACE Medical Writing, Norfolk, VA

“I Can Help You If You Would Just Let Me!”:  
The Journey From Vendor to Trusted Partner
An Interview with Demetrius Carter

REGULATORY INSIGHTS



174    AMWA Journal / V36 N4 / 2021 / amwa.org        

REGULATORY INSIGHTS

Transparency and Disclosure

CROs should meet and exceed compliance requirements by 

providing services such as data anonymization and redac-

tion powered by AI, clinical trial postings and result disclosure, 

plain language summaries, and strategies to promote patient 

engagement.

 Although the outlined approach may be ideal for large 

CROs, smaller organizations may not have the financial 

resources to establish all 5 components. For example, signifi-

cant technology investments may be too costly for small CROs. 

In this situation, these organizations may choose to focus 

on achieving operational excellence and raising their profile 

through consistent and high-quality delivery of their medical 

writing and regulatory affairs services.

AMWA: What Are Some Primary Reasons for a Failed CRO–

Pharmaceutical Company Relationship?

Carter: Some of the primary reasons for a failed CRO–phar-

maceutical company relationship include failing to deliver the 

document by the agreed upon timeline, delivering a document 

of poor quality that does not meet expectations or industry 

standards, missing a return on investment when the cost of 

services for the deliverable does not match the pharmaceutical 

company’s perceived value, and a failure to address ongoing 

performance concerns within the relationship.

AMWA: How Can CROs Show Their Value to Pharmaceutical 

Companies?

Carter: By developing a unique value proposition (UVP). 

This will describe the benefits the CRO can provide, and what 

makes these benefits valuable to the pharmaceutical company. 

The UVP should be focused and easy to articulate. For this to 

occur, the CRO must understand the pharmaceutical compa-

ny’s challenges and describe how the CRO’s service will address 

those challenges. The CRO must also present key differentia-

tors that distinguish its services from those of other CROs and 

describe the key benefits it brings to the table. Finally, the CRO 

must craft a message that demonstrates the value of their solu-

tion to the pharmaceutical company.

AMWA: How Can Writers Improve Their UVP?

Carter: To improve their UVP, writers should regularly review 

and reflect upon their performance by using a 360-degree 

review process that includes a self-evaluation. In addition, 

writers should choose 1 to 2 areas to improve upon annually, 

such as technical skills, knowledge, abilities, or competencies. 

A writer should compare the quality of the services provided 

with the fee the writer charges. This fee should be commen-

surate with the writer’s experience and the service provided. 

Finally, writers should find opportunities to innovate, such as 

the use of technology to improve the quality and efficacy of 

their documents.

 In the book, Good to Great, Jim Collins describes the 

Hedgehog Concept.2 This concept is based upon understand-

ing the intersection of 3 circles (Figure 1). When using these 

circles, writers should consider

1. Passion. To be the best, writers should only focus on 

activities they can be passionate about.

2. Excellence. Being good at something is not enough. 

Writers must understand what they can excel at to truly 

be great.

3. Drive. Know what activities drive consistent and reliable 

capital and profitability.

All 3 circles are required to transition from being good to being 

great. At the intersection of these circles is the target goal.

AMWA: How Can Writers Create Credibility When They Are 

New to a Team?

Carter: To create credibility,

• be accountable,

• demonstrate technical acumen,

• give and earn respect,

• talk less and act more, and

• demonstrate commitment.

AMWA: How Can Writers Manage a Team Without Authority?

Carter: Leading peers or more senior team members through 

document preparation requires writers to

• understand the team goals and motivators,

• set and document expectations at the project’s start,

• be an empathetic listener,

• hold team members accountable through consistent  

follow-up,

• create positive visibility for team members, and

• master their emotional intelligence.

Remember that managers control and direct but that leaders 

influence and inspire.

Figure 1. A depiction of the Hedgehog Concept.  
Adapted from The Jim Collins website.3

Passion

DriveExcellence



      AMWA Journal / V36 N4 / 2021 / amwa.org    175

REGULATORY INSIGHTS

AMWA: Do You Have an Example of a Pharmaceutical Com-

pany Hiring a CRO for Its Expertise but Then Not Using This 

Expertise? If So, How Do You Recommend Mitigating the Issue?

Carter: Yes. In this example, a pharmaceutical company hires a 

CRO for its therapeutic expertise and experience with the Food 

and Drug Administration (FDA) Center for Drug Evaluation 

and Research Office of Rare Disease, Pediatrics, Urologic, and 

Reproductive Medicine. In their desperation to accelerate their 

New Drug Application (NDA) submission due to competitive 

pressures and their desire to be first to market, the company 

asks the CRO to write their summary of clinical safety and the 

integrated summary of safety with only 1 year of data, although 

FDA guidance suggests at least 2 years of pivotal safety data. 

This places the NDA at risk for rejection by the FDA.

 To mitigate this issue, the CRO should transparently share 

its concerns and prior experience and ensure that communica-

tion reaches key stakeholders. Risks and mitigation strategies 

should be documented in meeting minutes. Finally, the CRO 

should stay motivated and demonstrate its technical expertise 

by delivering a quality document.

AMWA: Do You Have an Example of a Pharmaceutical 

Company and CRO Not Agreeing on a Timeline? If So, How Do 

You Recommend Mitigating the Issue?

Carter: Yes. In this example, the pharmaceutical company and 

CRO agree in a contract that the Clinical Study Report (CSR) 

for a pivotal study will have 2 drafts and a final draft; however, 

the tables, listings, and figures (TLFs) will not be available until 

the final draft. This CSR is on the critical path for the NDA sub-

mission. Here, the issue becomes the late delivery of the TLFs, 

which leads to compressed timelines for delivery of the final 

CSR and a limited time for a full quality-control review. In this 

situation, the delays with the final draft are leading to a pro-

tracted review cycle with the introduction of new reviewers 

and new stakeholders.

 Missing timelines or producing poor-quality deliverables 

can negatively impact long-term credibility and goodwill. To 

mitigate this issue, the writer, and project manager, if available, 

should assert themselves and push back. For example, they 

can advise the pharmaceutical company of the consequences 

of this shortened review cycle, and of changing reviewers and 

stakeholders. They should partner with the pharmaceuti-

cal company to negotiate a realistic timeline. To speed docu-

ment development while the TLFs are not available, the writer 

should develop a shell CSR by using draft or placeholder data 

and seek approval by using the agreed upon template. In 

addition, the writer should identify quality risks and mitiga-

tion upfront (eg, using draft data). Finally, the writer should 

use online review technology (eg, PleaseReview) to facilitate 

authoring followed by comment-resolution meetings.

AMWA:Do You Recommend That Medical Writers Increase 

Their Project Management (PM) Skills? If So, What Skills or 

Concepts Are Important to Project Management?

Carter: Yes. Upskilling your PM skills is critical to increasing 

your effectiveness as a medical writer. Pharmaceutical  

companies are increasingly expecting medical writers to take 

a leadership role within the submission team. PM is multifac-

eted and includes communication, teamwork, analysis, project 

planning, establishing a budget, establishing goals, under-

standing risks, problem solving, meeting deadlines, and reach-

ing milestones.

 Medical writers should be aware of 2 project management 

theories. In the first theory (Figure 2),4 a project has 3 limita-

tions: time, cost, and scope. Time refers to the project timeline, 

cost refers to the budget established for the project, and scope 

refers to the project purpose and requested deliverables.  

 A change in any one of these limitations will require an 

adjustment to the remaining limitations. For example, if the 

pharmaceutical company requires an expedited timeline, the 

cost of the project would increase as more writers are allocated 

to its completion. Additionally, quality is a key factor with this 

theory because changes to any of the limitations may affect the 

quality of the deliverable.

 An updated version of this theory (Figure 3)4 shows quality 

as a fourth limitation. Customer satisfaction becomes the key 

factor in this second theory, as a project’s success is defined  

Time

ScopeCost

Quality

Customer 
Satisfaction

Figure 2. Project Management Theory 1.  
Adapted from the Skill Point website.4

Scope

Time

Cost

Quality

Figure 3. Project Management Theory 2.  
Adapted from the Skill Point website.4



176    AMWA Journal / V36 N4 / 2021 / amwa.org        

REGULATORY INSIGHTS

by meeting or exceeding a customer’s (pharmaceutical com-

pany’s) expectations.

 

AMWA: Do You Have an Example of a Pharmaceutical 

Company Losing Confidence in a CRO? If So, What Advice 

Do You Have for the CRO to Regain the Pharmaceutical 

Company’s Confidence?

Carter: Yes. In this example, the pharmaceutical company 

and CRO have been in a long-term consulting relationship; 

however, the last few projects have not gone well, which 

has resulted in the projects being pulled back in house. 

Additionally, there have been changes in the internal lead-

ership of the pharmaceutical company, which has led to a 

decline in outsourced projects to the CRO. Here, the issues 

include the negative feedback on recent projects and the rela-

tive anonymity of the CRO in terms of the new leadership at 

the pharmaceutical company.

 Confidence can be lost overnight, and regaining confi-

dence takes a significant amount of time. To mitigate this issue, 

the CRO should review the performance feedback and develop 

a corrective action plan, collaborate on the lessons learned, 

and take accountability. It can then offer some concessions to 

the pharmaceutical company, such as a lower rate or credit for 

future work. A cooling-off period may be necessary. In addi-

tion, successfully completing lower-complexity tasks may help 

reestablish credibility.

AMWA: Do You Have Any Proven Techniques for Transitioning 

a Business Relationship Toward a Partnership?

Carter: Yes. To strengthen and transform the CRO–pharmaceu-

tical company relationship into a strategic partnership, a CRO 

must build TRUST with the pharmaceutical company. TRUST 

is an outward expression of the value proposition a CRO brings 

to the partnership. The letters of this acronym represent the 

qualities the CRO must demonstrate:

• Technical competency—knowledge and skills to success-

fully complete the deliverable

• Reliability—trustworthiness and consistent performance

• Unity on purpose—understanding and alignment with 

the pharmaceutical company’s goals

• Service orientation—priority being given to the pharma-

ceutical company’s needs and excellent customer service

• Transparency—discussion of any issues and advice 

based on experience

AMWA:What Are the Key Takeaways for Transitioning From a 

Relationship to Partnership?

Carter: For a CRO to transition from a transactional relation-

ship to a strategic partnership with a pharmaceutical company, 

there are 3 takeaways:

• manage projects effectively,

• create and deliver on the UVP, and

• establish value through TRUST.

Author declaration and disclosures: The author notes no commercial 
associations that may pose a conflict of interest in relation to this article.

Author contacts: Diana Henzel, dianahenzel@gmail.com; Demetrius 
Carter, demetrius.carter@certara.com

References
1. Carter D. “I can help you if you would just let me!”: best practices in 

overcoming a challenging sponsor. Presented at: AMWA Carolinas 2021 

Spring Conference; May 7, 2021; virtual.

2. Hedgehog Concept in the business sectors. Jim Collins website. 

Published 2021. Accessed June 28, 2021. https://www.jimcollins.

com/article_topics/articles/hedgehog-concept-business-sectors.

html#articletop

3. The Hedgehog Concept. Jim Collins website. Published 2021. Accessed 

June 28, 2021. https://www.jimcollins.com/concepts/the-hedgehog-

concept.html

4. Project management: what is the ‘Triple Constraint’ model? Skill Point 

website. Published September 18, 2018. Accessed June 28, 2021. https://

www.skillpoint.uk.com/triple-constraint-model/

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