Our Expertise

---

KINETIC has four practice domains: Clinical Development, Medical Science, Regulatory Science and Scientific Research. 

Clinical development is at the frontier of modern-day science enabling breakthrough state-of-the-art innovative therapeutics to be rigorously tested in clinical trials before they are approved and made available to patients. Cancer, neurodegenerative disorders and infectious diseases all have increasing morbidity and mortality rates globally with wide-ranging and life-limiting impact on patients. The need for new effective medicines is of paramount importance to improve patient prognosis, enhance quality of life and reduce the ever-growing global healthcare burden. 

Clinical research is a highly technical and challenging enterprise and clinical failures are inevitable, which may arise for many reasons such as poor patient recruitment, tenuous clinical considerations, lack of resources or translational product ineffectiveness in specific patient populations. Most often, failure may be due to inadequate strategic planning, oversights or lack of scientific or clinical due diligence for program or clinical study development at the outset. 

At KINETIC, we recognize the need to mitigate risks and work intensively with clients to design innovative and robust clinical trial strategies and programs thereby providing end-to-end assistance with preclinical and clinical development from inception to completion. Our philosophy is based on a comprehensive scientific understanding of research pathways, effective use of preclinical and clinical data, comprehensive knowledge of European and North American regulatory guidelines, and careful consideration of the intricacies of specific drug development strategies both for the product and for the client.

KINETIC Clinical Development is dedicated to designing and delivering robust evidence-based clinical development strategies and solutions. Our work supports the successful achievement of critical clinical development milestones and accelerated approval of innovative therapeutics.  

Medicines that have successfully navigated the complex clinical development process having achieved regulatory approval must adhere to strict medical information guidelines to ensure healthcare providers and patients have access to accurate, evidence-based promotional and non-promotional material, such as Prescribing Information and medical education multimedia. 

KINETIC’s Medical Science provides specialist pre- and post-registrational solutions and services for medical affairs teams to develop new product launches, create disease awareness campaigns, design publication planning strategies, and support product line extensions or reclassifications (eg, Rx to OTC). Our service line solutions are wide-ranging and include medical education and medical communications to events planning. 

KINETIC Regulatory Science assists biotechnology and pharmaceutical companies who are navigating the challenging pathway for regulatory approval of their products. From early pre-application strategies with Regulatory Health Authorities (RHA) to pre-registrational submissions, we advise, guide and support our client’s to achieve successful outcomes for their regulatory strategies and plans. 

We provide expert assistance for regulatory strategy development, RHA interactions and provide high-level expert regulatory writing support for Investigational Medicinal Product Dossier (IMPD)/Investigational New Drug (IND) Applications, Biologics License Applications(BLAs), Clinical Trial Applications (CTAs), Marketing Authorisation Application (MAA), and New Drug Applications (NDAs). We have an extensive portfolio of completed regulatory projects and our Regulatory Science Team can provide support from early development through to post-registrational regulatory activities.

KINETIC Scientific Research serves to support biotechnology start-ups and academic spin-outs. Our preclinical experts can assist with discovery biology strategies, preclinical toxicology and pharmacology program development, compound asset and portfolio evaluation, and clinical expertise to support pre-commercialisation and development plans. 

Our service line portfolio ranges from protocol design for bioanalytical and biopharmaceutical studies to Contract Research Organisation (CRO) vendor selection and management. We also conduct intensive research analysis and evaluations of clinical assets to determine viable market opportunities.  

KINETIC adopts GxP standards for all our practice areas, for example, we use industry gold-standard Electronic Document Management Systems (EDMS) that optimise cross-functional team collaboration, efficiency, transparency, consensus, and high-quality of muti-authored project work.

We also use customised, AI-assisted proprietary editing and proofreading software to support rapid authoring, editorial review, and Quality Control as a part of standard and best writing practices and Good Publication Practice (GPP). 

We support and utilise Quality Management Systems (QMS), Good Clinical Practice (GCP), and Good Pharmacovigilance Practices (GPPV) with respect to each of our practice areas.