Lex Clinical partners with your team and efficiently collaborates to design projects/trials that fit your business needs.

The clinical research landscape is evolving rapidly, driven by stricter regulations, technological advances, and growing expectations for faster, more cost-efficient trials. Companies are under increasing pressure to demonstrate safety, efficacy, and compliance while navigating complex regulatory frameworks.

Emerging trends such as decentralized trials, digital monitoring, and real-world evidence create both opportunities and challenges for clinical teams. At the same time, global expansion requires careful coordination to ensure compliance across multiple regions.

Lex Clinical stays ahead of these trends with innovative, flexible, and compliant solutions. Whether you're conducting a Phase I study or managing post-market surveillance, we provide the expertise and support you need to keep your clinical programs on track.

Project Management

Lex Clinical helps you successfully deliver your complex projects by navigating the challenges that arise throughout the clinical development process. On-time project delivery can be hindered by factors such as research complexities, ethical considerations, regulatory requirements, compliance issues, and the delicate balance between protocol and patient needs. Our expertise ensures that these challenges are addressed effectively, helping you stay on track and meet your goals.

With our strong communication skills, expertise in designing effective development plans, and advanced risk-analysis capabilities, we provide optimal solutions tailored to your needs. Whether you require end-to-end project management or temporary management support, we offer the focus and guidance necessary to successfully execute and complete your clinical development program.

Lex Clinical ensures that your clinical research is conducted efficiently, within budget, on time, and in compliance with regulatory requirements, while safeguarding patient safety and ensuring data quality. With our project management expertise, we lead your projects to the generation of reliable clinical evidence that can support new treatments or innovations in healthcare.

Clinical

Lex Clinical partners with your team and efficiently collaborates to design projects/trials that fit your business needs.

The clinical research landscape is evolving rapidly, driven by stricter regulations, technological advances, and growing expectations for faster, more cost-efficient trials. Companies are under increasing pressure to demonstrate safety, efficacy, and compliance while navigating complex regulatory frameworks.

Emerging trends such as decentralized trials, digital monitoring, and real-world evidence create both opportunities and challenges for clinical teams. At the same time, global expansion requires careful coordination to ensure compliance across multiple regions.

Lex Clinical stays ahead of these trends with innovative, flexible, and compliant solutions. Whether you're conducting a Phase I study or managing post-market surveillance, we provide the expertise and support you need to keep your clinical programs on track.

Clinical Development

Clinical development is a rigorous and highly regulated process aimed at ensuring new drugs, medical devices, and therapies are safe, effective, and suitable for public use. It involves a structured, multi-phase approach, with each phase building on the findings of the previous one, guiding the progression from early-stage testing to widespread public use. At Lex Clinical, we collaborate with you to optimize clinical trial design, implement patient-centric strategies, and guide you through the entire clinical development lifecycle. Our early-phase clinical development services are specifically engineered to accelerate study progression and bring your innovations to market faster.

No matter where you are in the clinical development process, our expert team is here to guide you. At each phase of clinical trials, we provide the necessary expertise to help you progress smoothly to the next stage and ultimately achieve a successful outcome with the appropriate regulatory agency. A well-formed clinical strategy is crucial for improving patient outcomes, optimizing healthcare delivery, and ensuring the efficient development of new medical products. Whether in healthcare delivery, clinical research, or pharmaceutical product development, a comprehensive strategy enables you to anticipate challenges, manage risks, and make informed decisions that align with both clinical and business goals.

With our scientific advice we can help you to ensure that developers perform the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during the evaluation of the marketing authorization application. This also helps avoid patients taking part in studies that will not produce useful evidence. For medicines, we can advise on the appropriate tests and studies required in the development or quality of a medicine. For medical devices, we can advise on clinical studies required in the development of high-risk medical devices.

Clinical Operations

Lex Clinical oversees the execution of clinical trials, ensuring that all operational activities are executed smoothly and efficiently, from start to finish.

The trial coordination is carried out jointly by all trial agencies involved and involves facilitating participation within the participating hospitals in the Netherlands. This service includes the following activities: preparing a new study in consultation with all those involved, discussing it and making working documents available for it, approaching hospitals about their wish to participate, supporting in obtaining the necessary ethical approvals, monitoring the implementation of the study, patient information provides and update and inform those involved about the start, participation, and progress of the study.

Clinical RA and Scientific Communication

We drive clinical projects to successful completion by collaborating with diverse stakeholders, ensuring seamless coordination in the input and review of each document. Our focus is on maintaining the highest standards of quality throughout every phase of the project. Lex Clinical provides both regulatory medical writing and educational medical writing services.

Regulatory medical writing services include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents (e.g. in Common Technical Document (CTD) format that summarize and discuss the data a company gathers in the course of developing a medical product.

Educational medical writing services are writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals. These include sales literature for newly launched drugs or medical devices, data presentations for medical conferences, medical journal articles for nurses, physicians and pharmacists, consumer or user education and programs and enduring materials for continuing education or continuing medical education. It plays a very important role in promotion of various pharmaceutical brands both to the health care professionals and the consumers or users.

Leadership

At Lex Clinical, we play an influential role in shaping your strategic business goals, as well as guiding the development of your product portfolio and clinical programs to align with your company's development roadmap. The format of our leadership roles is tailored to fit the unique needs of your organization, considering factors such as company size, culture, and corporate structure. Whether you require leadership at the C-Level or in a Program Lead role, we provide flexible solutions designed to meet your company's objectives and expectations.

As a C-Level executive, we lead your company with a strategic vision and a commitment to driving value at every stage of development. We empower science- and risk-based decision-making, manage operations effectively, and represent the company to stakeholders and partners. Our focus is on balancing innovation and operational efficiency to ensure sustainable growth while maintaining the highest standards of quality, safety, and compliance.

As a Program Lead, we take ownership of delivering a superior experience by developing our team's skills and providing guidance in their work. Our approach is defined by decisiveness, effective communication, and resourcefulness. We excel at adapting to changing priorities while staying focused on achieving goals and targets. Through strong day-to-day oversight, we ensure that the development program remains on track, guiding the team toward success and continuous improvement.

Interested in how we can lead your development toward success? Leave us a message.