Clinical Development
Tailored Clinical Development services to advance faster your Product to the Patients
Our top areas of ophthalmology expertise
Front of the eye indications such as:
Back of the eye indications such as:
Our tailored Clinical Development services
Explore a wide range of services tailored to your needs.
Bridging preclinical to FIH
Being able to identify and connect the key elements needed to transition smoothly to your First-In-Human (FIH) trial requires specific cross-functional expertise.
We help you design your FIH trial based on the CMC progress of your product and the non-clinical GLP and non GLP information available.
We ride you through your Scientific Advice Meeting with the authorities and help build your protocol accordingly, thus maximizing your probability of success. Our services also include authoring the related documentation such as IMPD, and preparation of your first submission dossier to relevant authorities.
Clinical Development Plan
A clinical development plan (CDP) is a strategic document that outlines the objectives, methodology, and timeline for the clinical development of a pharmaceutical product or medical intervention. It serves as a roadmap for navigating the various stages of clinical trials required to demonstrate the safety and efficacy of the product, ultimately leading to regulatory approval and commercialization.
Our expert team develops well-defined CDPs to guide you towards the successful execution of clinical trials and advancing the development of your new medical interventions from the laboratory to the clinic.
Clinical Development Infrastructure
We conduct a gap analysis of your existing Clinical Development infrastructure to identify inefficiencies and hidden risks that could potentially impact your clinical programs. Following this analysis, we develop a mitigation plan that outlines prioritized actions to address these issues, aiming to enhance team confidence, boost engagement, and elevate the efficiency and productivity.
By implementing these measures, we help you achieve significant cost savings and gain better control over your finances. This strengthened foundation will empower you to design and execute clinical programs with confidence, equipped with the most effective tools.
Medical Writing
We specialize in crafting a variety of clinical study documents essential for the successful execution of trials. Our expertise encompasses the development of Clinical Study Protocols, Clinical Study Reports (CSRs), Regulatory Submission Documents (IND, CTIS, NDAs).
Beyond clinical study documentation and regulatory writing, we offer a range of services to support scientific dissemination and medical education. This includes Scientific Manuscripts and Medical Communications for healthcare professionals, patients, and other stakeholders.
MSL / Medical Service in EU
Are you a fast-growing Biotech or Medtech willing to broaden your medical outreach in EU? Do you need tailored MSL services to do so?
We develop and engage your KOL and PI network. We provide scientific communication of KOLs and HCPs, support your medical events and partner with your clinical development. In addition, our team help operations during clinical trials identify the right sites with the right patients, engage with the PIs, support site activities in order to ensure alignment with the global team.
Biostatistics
We specialize in a range of services including study design, analysis planning, reporting, interpretation, and programming, data management planning and the management of clinical data throughout trials.
Our partner comprises seasoned biostatisticians and data scientists with extensive industry experience in ophthalmology across all phases of clinical trials and academic research.
We possess a deep understanding of ICH/GCP requirements and meticulously adhere to FDA, EMA, and EFSA standards, backed by direct FDA submission experience. We stay updated with the latest guidance, such as the ICH E9 addendum and considerations related to the implications of the COVID-19 pandemic.
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Connect with us to explore how we can make your vision a reality.
Join us in shaping the future of Product Development in Ophthalmology.