Outstanding client support is becoming increasingly critical across industries, and the life sciences sector is no exception. As innovation in research and development accelerates, providing clients with expert guidance throughout drug development, study management, and regulatory processes is more essential than ever. In this article, we hear from Rachel Harper, Vice President of Client Implementation Services and Outsourced Services, as she highlights how client support drives sustained success in life sciences, and how organizations can empower their clients to navigate a rapidly evolving and dynamic landscape with confidence.
Tell us about your history & role here at Instem.
I first became involved with SEND (Standard for Exchange of Nonclinical Data) in 2013, while working for a large CRO in the north of England. I became the company’s subject matter expert for SEND implementation, leading efforts to:
- Build a validated SEND team and systems.
- Align our data collection and processes with the new regulatory requirements.
- Get the organisation ready for the December 2016 SEND mandate for regulatory submissions.
My work extended beyond the company as well – I became a CDISC volunteer and started contributing to SEND standards development. I began with the developmental and reproductive toxicology standards, helped shape SEND IG 3.0 (which covers general tox and carcinogenicity studies), and more recently I’ve had the privilege of leading the Pathology Subteam for SEND IG 4.0.
Rachel Harper: VP Client Implementation & Outsourced Services, Instem
I joined Instem in December 2016, just as SEND became a regulatory requirement and just as Instem’s SEND team was starting to grow. At the time, there were only six people working on SEND. It was a fantastic opportunity to build something. I had the pleasure of recruiting, educating, and developing a team of people who knew nothing about SEND and turning them into subject matter experts. Under my leadership, the SEND team has expanded to around 40 people, becoming one of the largest groups within Instem’s Outsourced Services division. Now, my official role is VP Client Implementation & Outsourced Services, and I look after two key areas: Client Implementation Services and Outsourced Services.
Client Implementation Services focuses on helping our customers successfully adopt Instem software and get the most value out of it. I have three teams:
- Education Services: This team trains our external customers on how to use the product, but also trains our internal teams. For example, they educate our support teams who will be running the helpdesk, or our sales enablement team who need to understand new functionality so they can communicate it effectively to customers.
- Implementation Consultancy: This team works with customers to optimize their workflows and system configurations. If a customer is transitioning from one system to another, they might write SQL to help migrate data or rebuild critical data lexicons. They run workshops to find small workflow tweaks that can have a big impact – for example, how study protocols are set up or how a task is sequenced.
- Technical Services: Responsible for installing our systems. We’re increasingly moving customers to hosted environments, but we still support dedicated hosted solutions and some on-premise customers, though we’re working to transition away from that.
The second part of my role is Outsourced Services, where we deliver services that use Instem products to produce deliverables for customers.
Can you expand on Outsourced Services – what does that cover?
The largest part is SEND services – we have about 40 people in that team. They standardise nonclinical study data into SEND format so it’s submission-ready for regulators like the FDA. This helps sponsors get new drugs into clinical trials or take them to market faster.
We also offer: KnowledgeScan, Advance, and Predict Services. These help pharma companies in the discovery phase, assessing impurities and selecting good candidates for development.
Regarding the Advance S1B Services – This is a relatively new service based on the FDA’s S1B guideline. It produces a weight-of-evidence assessment to show that a two-year carcinogenicity study may not be needed. These studies are extremely expensive and time-consuming; you’re looking at two years of in-life study plus pathology and reporting, so being able to avoid them can save three to four years in drug development and millions of dollars. It also significantly reduces the number of animals used in research, which is a major step forward.
I’m also working on acquiring a consultancy team to expand our staff augmentation and project management offerings – giving customers access to experienced project managers, validation experts, or SEND data creators as an extension of their own team.
What are you most passionate about in your role?
For me, it’s about two things:
The external impact. The work we do at Instem directly contributes to bringing new medicines to market. My Dad has metastatic melanoma, and the immunotherapy treatment that saved his life is one we helped support. To know that my team played a part in that drug’s development is incredibly powerful.
The people aspect. I get a lot of satisfaction from building strong, high-performing teams who deliver real value to customers. When our teams are thriving and collaborating, that’s my perfect day.
What advice would you give to organisations creating SEND datasets?
- My biggest recommendation is to think about SEND early – ideally when you’re setting up your study protocol and configuring your data collection systems.
- Make sure your test codes are consistent and SEND-friendly.
- Plan how to incorporate data from external sources, especially if you’re still collecting anything on paper.
- Work with third parties who can provide SEND-ready files or structured data that’s easy to integrate.
Doing this early streamlines the process, shortens timelines, and avoids time crunches when you’re preparing for IND submissions.
How do you balance overseeing both Client Implementation Services and Outsourced Services?
It’s definitely a juggle every day! But I’m fortunate to have two fantastic leaders – Iain Graham, who heads Client Implementation Services, and Stephanie Berry, who manages Outsourced Services. Both are strong leaders with great teams underneath them, and that makes a huge difference.
Good team structure and strong communication mean we spend less time firefighting and more time focusing on optimising workflows and delivering value to our customers.
Finally, what’s next for your teams?
We’ll continue expanding our consultancy post acquisitions and staff augmentation services to meet growing customer demand. There’s also a lot happening in the SEND space, with CDISC SEND IG 4.0 coming soon – bringing new study types and data types into scope. That means we’ll have even more opportunities to help customers optimise submissions and bring new treatments to market faster.
Thank you for your time, Rachel!
In this conversation, we highlighted the services that Rachel and the Operations Team provide – from implementing and optimising Instem software for customers, to delivering SEND and other outsourced services that accelerate drug development and enhance data quality. Instem’s expertise ensures that customers can streamline workflows, meet regulatory requirements efficiently, and ultimately bring new medicines to patients faster. It’s clear that the services the team provides make a real difference, both to our customers and to the wider life sciences community.
