Case Histories

A few handy example cases from 25 plus years of delivery, showcasing our experience and capabilities.

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Clinical Operations

ReCode is developing therapeutics for genetically defined diseases with no existing treatment options including cystic fibrosis and primary ciliary dyskinesia.

ReCode Therapeutics is a US-based, clinical-stage genetic medicines company is developing therapeutics for genetically defined diseases with no existing treatment options including primary ciliary dyskinesia and cystic fibrosis.

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Regulatory Affairs

Erytech Pharma is a clinical-stage biopharmaceutical company best known for its proprietary ERYCAPS® red cell encapsulation platform

Erytech Pharma SA is a clinical-stage biopharmaceutical company based in Lyon, France, best known for its proprietary ERYCAPS® red cell encapsulation platform, which it uses to produce red cell-based therapeutics to treat patients with rare forms of cancer and orphan diseases. Erytech’s lead product candidate, eryaspase (red cells encapsulating asparaginase), is currently in Phase 3 […]

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Regulatory Affairs

DemeRx is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of addiction.

DemeRx is a US-based clinical stage pharmaceutical development company advancing drug candidates as therapies for addiction. It is currently evaluating patient data which demonstrate that a single dose of ibogaine may be sufficient to detoxify opioid-dependent persons and diminish drug cravings for extended time periods. As part of their clinical plan, DemeRx is evaluating the […]

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Medical writing

Cleothena Enterprises Pty Ltd. is a forward-thinking biotechnology company focused on advancing innovative therapeutic solutions.

Cleothena Enterprises Pty Ltd. is a forward-thinking biotechnology company focused on advancing innovative therapeutic solutions through precision science, robust clinical strategy, and streamlined regulatory engagement. Specialising in the development and communication of high-quality clinical and scientific materials—such as clinical protocols, Investigator’s Brochures, and regulatory documentation—Cleothena supports biopharmaceutical organisations in accelerating their development programs with clarity, […]

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Medical writing

BSH is the UK’s largest haematology organisation, promoting excellence within the field and supporting professional development.

The British Society for Haematology (BSH), the UK’s largest haematology organisation, promotes excellence within the field and supports the professional development of over 3000 members.

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Publication planning

Cardionetics is an innovative hardware and software solutions company specialising in providing intelligent systems for diagnostic, monitoring, and screening purposes.

Cardionetics is an innovative hardware and software solutions company specialising in providing intelligent systems for diagnostic, monitoring, and screening purposes.

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Medical writing

Recardio Inc is a life science company that focuses on drug-based regenerative therapeutic modalities for treatments of cardiovascular diseases.

Recardio is a life science company that focuses on drug-based regenerative therapeutic modalities for treatments of cardiovascular diseases.

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Clinical Operations

Surface Logix is a drug development company using biophysical chemistry to create new small molecule drugs.

Surface Logix is a drug development company which uses its expertise in biophysical chemistry to create new small molecule drugs with significantly improved pharmacokinetic and pharmacodynamic properties compared with class leaders.

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Medical writing

A specialist pharmaceutical company dedicated to HIV medicines and research with an extensive portfolio of prescription medicines.

A specialist pharmaceutical company dedicated to HIV medicines and research with an extensive portfolio of prescription medicines.

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Medical writing

A specialist respiratory biotech company whose primary focus is developing our investigative inhaled IFN-β for the treatment of severe viral lung infections.

Synairgen is a UK-based biopharmaceutical company focused on developing innovative treatments for respiratory diseases, particularly known for its lead product, an inhaled interferon beta (IFN-β) for severe viral lung infections.

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Regulatory Affairs

Orchard focuses on key competencies internally, while engaging with bespoke service providers to deliver important aspects of their business.

Following the acquisition of Strimvelis and associated gene therapy assets by Orchard Therapeutics, our contributions were formally acknowledged as foundational to the success of the regulatory submission. Recognizing the depth of our experience and our commitment to scientific excellence, Orchard Therapeutics re-engaged our team to support the preparation of a new regulatory submission for an […]

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Medical writing

Nabriva Therapeutics is committed to developing new antibiotics to treat infectious diseases.

Nabriva Therapeutics was incorporated as a spin-off from Sandoz GmbH Antibiotics Research Institute (ABRI) in Vienna. The new organisation included small molecule assets, including pleuromutilin structure activity relationships (SAR) knowledge, and focused on synthesis of pleuromutilins for systemic human use. Following identification of their lead compound lefamulin and based on its clinical results for acute […]

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Regulatory Affairs

EVERSANA is a leading independent provider of global services to the life sciences industry.

EVERSANA is a leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organisations, including innovative start-ups […]

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Medical writing

QC review of an IB update for uzatresgene autoleucel, one of Adaptimmune’s TCR-based therapies.

Adaptimmune specialises in developing novel therapies for the treatment of resistant tumour types.

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Medical writing

The FRAILOMIC initiative was an international research project

The FRAILOMIC initiative was an international research project aimed at improving the understanding, diagnosis, and management of frailty in older populations.

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Programme Coordination

A consortium of academic centres and leading pharmaceutical companies in asthma

The RASP-UK initiative, or Refractory Asthma Stratification Programme, is a UK-based research effort designed to transform the management of severe asthma by adopting a more personalized treatment approach.

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Medical writing

Specialising in the discovery and development of small-molecule drugs for oncology and central nervous system disorders.

Astex employs its proprietary Pyramid™ platform to develop innovative therapies targeting challenging or “intractable” diseases.

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Publication planning

A medical device company that was involved in the manufacturing of orthobiologics.

ApaTech was a medical device company that was involved in the manufacturing of orthobiologics, specifically the development of synthetic bone graft materials to enhance bone repair and regeneration.

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Medical writing

Partnership with a clinical research organisation specialising in comprehensive data services for clinical trials.

Assign’s business model relied on bespoke service providers like Niche to deliver essential aspects of their business delivery model.

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Clinical Operations

Providing a range of regulatory, medical writing and clinical operations services

A 30 person not for profit biotech focused exclusively on discovering superior therapeutics for the treatment of cystic fibrosis.

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Regulatory Affairs

Providing a broad range of services, as a trusted CRO to help Funxional realise its clinical vision

Funxional Therapeutics Ltd was a privately-held pharmaceutical start-up. It was set up in 2005 to commercialise the development of broad-spectrum chemokine inhibitors.

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Clinical Operations

A fully integrated clinical research organisation with its own purpose-designed clinical pharmacology unit.

Hammersmith Medicines Research (HMR) is a fully integrated clinical research organisation with its own purpose-designed clinical pharmacology unit.

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Regulatory Affairs

A small but ambitious company with a pioneering vision for their arenavirus platform

HOOKIPA Pharma is a small but ambitious company with a pioneering vision for their arenavirus platform

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Regulatory Affairs

Evolving study designs and managing complex data outputs to present a comprehensive regulatory package

iOnctura is a clinical-stage biopharmaceutical company that benefited from our history with oncology indications, to consolidate an evolving study design and manage complex data outputs to present a comprehensive package.

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Regulatory Affairs

Niche was invited to provide support for the development of the regulatory documentation for OC134, a reformulation of tacrolimus

Nanomerics’ mission is to deliver augmented medicines with improved activity and fewer associated side effects through the application of materials science.

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Publication planning

Research and development of innovative vaccines, pharmaceuticals and biologics.

Petrovax is a Russian biopharmaceutical company established in 1996, specializing in the research, development, and production of innovative vaccines, pharmaceuticals, and biologics.

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Clinical Operations

Supporting the development of innovative therapies for respiratory diseases, particularly those caused by viral infections and other acute respiratory conditions.

Pulmocide is a company dedicated to developing innovative therapies for serious respiratory diseases, focusing on viral infections and acute respiratory conditions.

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Clinical Operations

Realising a mission to improve the quality of life for individuals with respiratory conditions

Respivert was a clinical-stage biopharmaceutical company that benefited from our history and experience with asthma.

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Medical writing

Providing regulatory and medical writing support to meet client needs

Scandinavian Development Services Life Science was a leading consultancy in the Nordics with regards to regulatory guidance, design of clinical trials and expertise in biostatistics.

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Legal Rep

A clinical-stage biopharmaceutical company seeking regulatory support

Sorriso is a biopharmaceutical company advancing a pipeline of disease-modifying antibodies for the treatment of immune-mediated diseases, including Crohn’s disease and ulcerative colitis. 

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Regulatory Affairs

Services were tailored to meet the differing requirements of the regulatory pathway, including providing various study documents and updates.

VectivBio has evolved from a small biotech in engaged in early development into an organisation actively planning and rapidly approaching its own submissions for global commercialisation.

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