Clinical Development Solutions

At R-S-S, we offer comprehensive, tailored services designed to accelerate and optimise your drug development process. We specialise in early phase clinical trials, providing expertise in study design, protocol development, and regulatory compliance to ensure scientifically rigorous and ethically sound clinical trials.

PK/PD Insights for Therapies

We specialise in pharmacokinetic (PK) and pharmacodynamic (PD) Modelling and Simulation, a critical aspect of drug development that helps in understanding the relationship between drug dosage, exposure, and therapeutic effects. Our advanced Pop PK/PD modelling and simulation services support the optimisation of dosing regimens, enhance the efficacy and safety of new therapies, and facilitate informed decision-making throughout the drug development process.

Our Services

Clinical Trial Design & Protocol Development

Our teams provide comprehensive guidance in designing clinical trials, ensuring that they are scientifically robust, ethically sound, and regulatory compliant. We assist in protocol development, study design optimization, and endpoint determination to maximize the efficiency and success of your clinical trials.

Clinical Trial Applications (CTAs)

We offer expert support in preparing and submitting Clinical Trial Applications (CTAs) to regulatory authorities. Our services include compiling necessary documentation, ensuring compliance with local and international regulations, and facilitating smooth interactions with regulatory bodies to expedite trial approvals.

Data Management

Effective data management is crucial for the success of clinical trials. We offer robust data management services, including data collection, validation, analysis, and storage. Our systems ensure data integrity, security, and compliance (e.g. 21 CFR Part 11) with regulatory standards, providing reliable data for regulatory submissions and decision-making.

Clinical Trial & Information Systems

We provide advanced solutions for Clinical Trial and Information Systems (CTIS), integrating technology to streamline trial management and data handling. Our CTIS services enhance efficiency, improve data accuracy, and ensure compliance with regulatory requirements throughout the trial lifecycle.

Applications & Submissions Quality Control

Quality control is a critical aspect of regulatory submissions. Our teams conduct meticulous reviews of all application and submission documents to ensure accuracy, completeness, and compliance with regulatory standards, reducing the risk of delays or rejections.

Medical Report Writing

Our medical writing experts produce high-quality medical reports, including clinical study reports, investigator brochures, and regulatory submission documents. We ensure that all reports are scientifically accurate, clearly written, and compliant with regulatory guidelines, supporting successful regulatory reviews.

Clinical Expertise

With extensive clinical expertise across various therapeutic areas, our teams provide valuable insights and support throughout the clinical development process. We assist in clinical trial design, protocol development, and the interpretation of clinical data, ensuring the highest standards of clinical research and patient care.

Disease Area Expertise

Our specialised knowledge in multiple disease areas allows us to provide targeted support for your clinical development programs. We offer expertise in areas such as oncology, cardiology, neurology, and rare diseases, ensuring that your trials are designed and conducted with a deep understanding of the specific challenges and regulatory requirements of each therapeutic area.

New Drug Applications & Submissions

Navigating the complex process of New Drug Applications (NDAs) is made easier with our expertise. We provide strategic advice and hands-on support in compiling and submitting NDAs, ensuring that all regulatory requirements are met to achieve timely approval and market entry.

Clinical Trial Design & Protocol Development

Clinical Trial Design & Protocol Development

Our teams provide comprehensive guidance in designing clinical trials, ensuring that they are scientifically robust, ethically sound, and regulatory compliant. We assist in protocol development, study design optimization, and endpoint determination to maximize the efficiency and success of your clinical trials.

Clinical Trial Applications

Clinical Trial Applications (CTAs)

We offer expert support in preparing and submitting Clinical Trial Applications (CTAs) to regulatory authorities. Our services include compiling necessary documentation, ensuring compliance with local and international regulations, and facilitating smooth interactions with regulatory bodies to expedite trial approvals.

Data Management

Effective data management is crucial for the success of clinical trials. We offer robust data management services, including data collection, validation, analysis, and storage. Our systems ensure data integrity, security, and compliance (e.g. 21 CFR Part 11) with regulatory standards, providing reliable data for regulatory submissions and decision-making

Clinical Trial & Information

Clinical Trial & Information Systems

We provide advanced solutions for Clinical Trial and Information Systems (CTIS), integrating technology to streamline trial management and data handling. Our CTIS services enhance efficiency, improve data accuracy, and ensure compliance with regulatory requirements throughout the trial lifecycle.

Applications & Submissions Quality Control

Applications & Submissions Quality Control

Quality control is a critical aspect of regulatory submissions. Our teams conduct meticulous reviews of all application and submission documents to ensure accuracy, completeness, and compliance with regulatory standards, reducing the risk of delays or rejections.