We are a bespoke clinical research organisation (CRO) dedicated to advancing pharmaceutical development. Our comprehensive suite of services is designed to support all phases of clinical development, ensuring regulatory compliance and facilitating successful project outcomes. Click below for more details.

Clinical Operations

Regulatory Affairs

Medical Communications

Regulatory Affairs

Regulatory strategy

Strategic scientific and regulatory support for drug development projects.

Regulatory writing

Preparation of the documentation required at each stage of clinical development represents a significant burden on clinical teams.

Quality review and QC services

Profiling within the scientific literature provides a major contribution to the successful launch of a product.

Agency communications and submissions

Expert Support for Agency Communications and Submissions.

Legal Representation

Expert Support for Legal Representation.

Quality review and QC services

Profiling within the scientific literature provides a major contribution to the successful launch of a product.

Quality review and QC services

Expert Support for Redaction, Quality Review and QC Services.

Clinical Operations

Clinical Project Management

Comprehensive Clinical Project Management for Successful Trial Execution.

Trial documents and delivery

Clinical trials require the production and maintenance of a wide range of essential documents to ensure that the trial is conducted in a rigorous and ethical manner

Trial Monitoring and site management

Our comprehensive clinical monitoring service is designed to ensure the integrity of your clinical trials.

Electronic trial master file management

We offer a comprehensive electronic Trial Master File (eTMF) services.

Quality management systems

Many of our clients give priority to their clinical objectives, like getting to FTIH trials or 'starting the next study'.

Strategic Communications And Medical Education

Strategic communications

Profiling within the scientific literature provides a major contribution to the successful launch of a product.

Grant submission support

Many of our clients give priority to their clinical objectives, like getting to FTIH trials or 'starting the next study'.

QC and submission services

As specialists in supporting successful grant applications, partnering with Niche will allow you to focus your resources on developing your project concept, leaving the task of building your grant application and planning your dissemination activities to our experienced team.

Publication planning and implementation

Changing regulation and increasing litigation is increasing the focus on pharmacovigilance (PV), general drug safety and clear information for patients.

Medical illustration

Niche can provide a most forms of artwork, from line and full colour illustration to template design, charts, graphs and tables for use in presentations and a range of other communication vehicles.

Medical education

We can create innovative training programmes for the effective education of your target audience: customers, representatives, scientists or patients. 
Regulatory Writing
Preparation of the documentation required at each stage of clinical development represents a significant burden on clinical teams.
Strategic Communications
Profiling within the scientific literature provides a major contribution to the successful launch of a product.

Clinical Project Management
Our team are eager to help you with the regulatory affairs support you need to facilitate the fast and efficient development of your innovative medicines.
Medical Education
We can create innovative training programmes for the effective education of your target audience: customers, representatives, scientists or patients.

Regulatory Strategy
Our team are eager to help you with the regulatory affairs support you need to facilitate the fast and efficient development of your innovative medicines.
Grant A8pplications
We tailor our services to fit your needs based on your scope of funding, organisation and the level of support you require. Our team can support all your writing needs.
Agency Communications and Submissions
Niche offers comprehensive support for the preparation of regulatory documentation, leveraging our access to extensive resources to ensure timely and accurate submissions.
Legal Representation
Your representative should be a reliable partner for the Sponsor providing comprehensive regulatory advice and expertise. We strive to offer our clients such a partnership.
Redaction, Quality Review and QC Services
Clinical trial transparency obligations are foundational to a Sponsor’s commitment to patient centricity.
Study Documents and Delivery
Clinical trials require the production and maintenance of a wide range of essential documents to ensure that the trial is conducted in a rigorous and ethical manner.
Study Monitoring and Site Management
Our comprehensive clinical monitoring service is designed to ensure the integrity of your clinical trials. The NST team of qualified professionals.
Trial Master File and Document Management
We offer a comprehensive electronic Trial Master File (eTMF) services. We understand the critical role of the TMF in managing and tracking the progress of clinical trials.
Quality and Vendor Management Systems
Many of our clients give priority to their clinical objectives, like getting to FTIH trials or 'starting the next study'.
Publication Planning
Publication planning and execution provides a compliant and coherent means of effectively communicating the scientific, clinical and health economic evidence supporting the value of your scientific activities.
Medical Illustration
Telling a story is essential to any presentation and our team integrates technical artistic ability with a comprehensive understanding of medicine and science.
Document Editorial, QC and Submission Services
Acceptance of your research by a journal or a scientific conference depends on its quality, content and goodness of fit to submission requirements.

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