About Lealto Consulting
Lealto Consulting provides specialised expertise in regulatory strategy, clinical science, trial design, operational support, and medical writing for early-phase clinical development. We offer bespoke consultancy services to pharmaceutical and biotechnology companies, contract research organisations (CROs), and clinical research institutions, ensuring tailored solutions for each client’s unique needs.
With over 20 years of industry and regulatory experience, Lealto Consulting combines deep scientific knowledge, regulatory insights, and a collaborative approach, making us an indispensable partner for successful early clinical development. We deliver pragmatic, timely guidance to optimise clinical and regulatory strategies, ensuring a streamlined path to trial completion.
The company is committed to delivering the highest quality medical writing services, ensuring that trial documents meet rigorous regulatory, safety, and ethical standards while incorporating the flexibility needed to minimise costly and time-consuming amendments.
Our commitment to excellence ensures that your clinical trials are scientifically and logistically sound, facilitating efficient execution, achieving optimal outcomes for your business.
Lealto Consulting was founded in 2024 by Dr Sally Dowen.
Dr Sally Dowen MA PhD CHP
Sally brings over 20 years of comprehensive clinical trial experience from first concept to final reporting. Her previous leadership roles include Head of Clinical Trials at the MHRA (the UK medicines regulator) and Director of Clinical Science and Regulatory Affairs at one of the UK’s most respected CROs (with overall responsibility for Clinical Project Management, Regulatory Affairs, and Medical Writing).
Her unique experience and clinical trials expertise combine regulatory rigour and scientific scrutiny, with trial logistics and problem solving, making her a valuable partner in achieving optimal trial outcomes. A people-focused leader, Sally integrates seamlessly with client teams, fostering open communication and providing practical guidance.
Sally is a specialist in early-phase development. She has overseen more than 200 phase I and II trials across a wide range of therapeutic areas, including: cardiovascular, CNS, dermatology, diabetes, endocrine, gastrointestinal, immunology, infectious diseases, pain, psychiatric, respiratory, and oncology.
She has contributed to the design, regulatory strategy, management and reporting of many trial types, including: adaptive, multipart first-in-human trials, single ascending dose (SAD), multiple ascending dose (MAD), food effect, ethnicity bridging, bioequivalence and bioavailability, interaction studies, ADME, thorough QT, PET, fMRI, trials involving patients and special populations, and trials of genetically modified organisms.
Sally’s hands-on experience covers a wide range of clinical research, including study design, setup and conduct, writing and providing expert input into protocols and study reports, making clinical trial authorisation (CTA) and ethics committee submissions, liaising with the MHRA, and presenting to the Commission on Human Medicines (CHM) and the Clinical Trials, Biologicals and Vaccine Expert Advisory Group (CTBVEAG).
Sally is Alternate Vice Chair of London–Brent Research Ethics Committee (flagged for review of clinical trials in children, phase 1 healthy volunteers, and gene therapy products), and a member of the UK Health Research Authority’s Phase 1 Expert Advisory Group and the MHRA’s Phase 1 Stakeholder Group. She is a guest lecturer at Kings College London for their MSc course in Drug Development Science. She has a BA in Natural Sciences (specialising in Cellular Pathology and Virology) and a PhD in Molecular Oncology both from Cambridge University, and a Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine of the Royal College of Physicians.
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