Driven, experienced and reliable

Since our establishment in 1998, Niche Science and Technology Ltd has delivered exceptional clinical research services to a distinguished portfolio of pharmaceutical and medical device organisations.

Our core expertise encompasses strategic regulatory affairs, comprehensive clinical project management, and specialised medical communications. We excel in navigating clients' therapeutic assets through all phases of clinical development and post-approval processes with precision and scientific rigor.

For over two decades, we have expanded by attracting high-calibre professionals who share our commitment to excellence.

Our team derives real pleasure from collaborating with clients to address complex scientific challenges and deliver innovative solutions that advance patient care.

What we can do for you

Specialising in regulatory submissions and clinical project management, we are experts at ensuring our clients successfully progress their assets through all phases of clinical development and commercialisation. Our approach is focused on delivering scalable solutions tailored to the specific needs of every client.

Our proven methodology combined with regulatory expertise, operational excellence, and scientific acumen ensures seamless progression of clinical programs while maintaining the highest standards of quality and compliance.

We have been rewarded for our efforts with the opportunity to work with outstanding scientists, academics and industry professionals dedicated to delivering cutting-edge science.

Our History

Niche Science & Technology was founded in London in 1998 as a specialist clinical research organisation (CRO) providing tailored medical writing, regulatory support, and clinical study management services to the pharmaceutical and biotech industries. Over the years, it has built a reputation for delivering high-quality, regulatory-compliant documents and clinical trial support across a range of therapeutic areas, with a particular strength in its offerings to the biotech sector. The company has grown organically through its commitment to scientific rigour, personalised client service, and an agile, collaborative approach to clinical development challenges.

Our Path of Progress

25+ Years of Innovation and Excellence

Scroll to explore our journey

Foundation &
Defining the Niche
1998-2005

1998

Company Founded

Launched as a specialist provider of regulatory and clinical writing services. Established core identity as a science-led, expert-driven organization.

1998-2001

First Major Client Engagements

Secured contracts with blue-chip pharma, delivering high-quality regulatory documents and strategic advice. Validated market need for specialized expertise.

~2003

Core Quality Management System

Implementation of robust, scalable system for document control, SOPs, and quality assurance. Laid operational foundation for future growth.

2005

Trusted Partner Reputation

Track record of successful deliveries led to repeat business and referrals. Transitioned from vendor to trusted partner for early-stage companies.

Strategic Expansion &
Service Integration
2006-2015

~2008

Integrated Service Modules

Expansion beyond regulatory to include early-phase clinical operations and full regulatory strategy. Became comprehensive development ally.

~2010

Cell & Gene Therapy Expertise

Early investment in understanding complexities of advanced therapies. Positioned NST as forward-thinking leader in high-growth sector.

2011

MHRA Assessment Passed

Successfully passed first MHRA assessment, demonstrating commitment to regulatory excellence and quality standards.

2012

MID-Frail Research Grant

Awarded first research grant (€5M) to conduct research into diabetes in elderly subjects, expanding into clinical research leadership.

2013

FRAILomic Research Grant

Awarded €7M research grant to identify markers and biomarkers of processes that turn frailty into disability.

2015

RASP-UK Research Grant

Awarded £5M (+match funding) to transform severe asthma diagnosis and management, paving way for new treatments.

Brand
Codification
2016-2020

2016

Insider's Insights Launch

Released first Insider's Insight, receiving over 20,000 downloads and establishing thought leadership in the industry.

2019

'Biotech in a Box' Launch

Integrated service model formally branded as distinct offering for cost-efficient biotech and start-up partnering.

2020

20+ Years Celebration

Significant anniversary highlighting resilience, stability, and long-term client relationships. Reinforced message of trust and continuity.

2020

Brexit Adaptation

Rapid deployment of UK Legal Representation and MHRA gateway services for non-UK sponsors, demonstrating agility.

2020

COVID-19 Virtual Expansion

Went virtual and expanded globally. Demonstrated thought leadership, partnering with over 150 biotechs worldwide.

The Agile Ally
2021-2025

2022

SME Agility as Core Differentiator

Promoted ability to form expert teams in days, not months. Targeting pain points of slow, bureaucratic large CROs.

2023

Enhanced 'Biotech in a Box'

Further refinement with Dedicated Service Modules including Regulatory Gateway, Strategic Communications, and CGT support.

2024

25+ Year Legacy Milestone

Celebration of quarter-century of service. Positioned as mature, stable, and expert partner for high-stakes development.

Into the
Future

Era 5: The Future

Sustained Leadership and Evolution

Defining the geographic scalability of our Biotech in a Box Model, serving a global client base without sacrificing the personal partnership approach that has defined our success.

Leadership Team

The Niche team comprises experts in regulatory affairs, scientific communications, and clinical operations. We are committed to client satisfaction through precise delivery of tailored solutions that meet timeline and budget requirements.

Our seasoned industry professionals stand ready to address your resource constraints and knowledge gaps with strategic precision. By thoroughly understanding your business objectives and strategic vision, we ensure our deliverables exceed expectations—providing not just what is requested, but what is genuinely required for your success.

Dr Tim Hardman

Managing Director

Tim established Niche Science & Technology in 1998 following a number of years in clinical trials research and medical.

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Dr Justin Cook

Head of Medical Writing

Head of Medical Writing since 2008, Justin joined Niche in 2001. Justin sets Medical Writing strategy in collaboration.

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Ammar Moussa

Business Manager

Ammar has been the Business Manager and IT supervisor at Niche for the last 6 years.

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Ruth Hardman

Finance Director

Ruth has been Finance Director at Niche for 7 of the last 10 years, managing company accounts, contracts and invoicing

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Dr Laura Lyons

Head of Clinical Operations

Laura took on the role of Head of Clinical Operations in March 2024, inheriting and expanding our fantastic clinical.

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The Niche Team

At Niche we adopt a set of cultural values that are inherent to everything we do. These translate into a dedication to.

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Join the team!

We are always looking for exceptional individuals to join our team. We give serious consideration to any application from client-focused candidates who are enthusiastic about medical science and can enhance our ability to deliver a top-quality service. Our collaborative approach to business leads to excellent team retention – the same person is often available throughout the life of client projects. Our small-team model promotes collaboration, innovation, and high ethical values, leading to an agile and balanced working environment.

Current Vacancies