Syntax for Science

Rescue study: Sometimes clinical studies experience some problems that do not allow to continue the project properly, among these the most frequent are usually lack of recruitment, or mismanagement of other aspects such as data management delays, a bad design in the protocol, etc. At Syntax we provide our team to analyze and respond to studies already underway that are experiencing problems. Whether it is the need to open new centers in another country, or to rethink the protocol and its design in order to optimize the development of the clinical trial, we can help you.

Feasibility or feasibility analysis: A strong and value-added point we offer to our clients is the elaboration and feasibility reports, both for national and international projects. Are you planning to perform a clinical study and do not know how much it can cost you? Is your phase II/III project international but do not know which countries would be better to include to have a quick start and an optimal recruitment? The availability of your medical product in other countries, regulatory and patient regulations (as well as the existence of competitive studies) are some of the aspects we analyze for you. Having a feasibility report to assess the logistics and implementation options for your study is crucial to avoid future problems. We have free and paid options, you can ask for more information to our business development department at info@syntaxfs.com.

Study design: We know that the study design is crucial for its approval, obtaining results and development in the market. Therefore, our medical department, led by the Director with more than 25 years of experience in the pharmaceutical sector, provides all the necessary support to optimize the configuration of the clinical trial taking into account the entire development chain of a drug or medical device. Aspects such as ethics, difficulty of recruitment and efficiency in data collection are taken into account when choosing the best design for your study.

Regulatory: We have experience in the regulatory management of studies with drug and also with medical device, both nationally and internationally. If your product is novel and you are not clear about the regulatory route, we can also help you! Not only with our experts, we have a network of collaborators with experience in advanced therapies and cosmetic products that require approval as a medical device.

Project management: We have a project management team, assigning our studies to the most appropriate manager according to the phase and scope of the study. Our managers have national and international experience, coordinating all activities on time, within budget, and following our quality system. We have risk mitigation plans in place to deal with personnel changes in the study, in case they need to be made, in order to minimize delays or management problems.

Clinical supervision: Our team of monitors is large and varied so that we can offer staff with previous experience in managing the therapeutic areas of our studies. We have senior monitors who supervise the projects and ensure proper data collection. All our monitors are properly trained and updated in the regulations of the sector, they also rigorously follow our quality system, as well as a risk plan previously elaborated to detect all those aspects that may affect the development of the study. We have more than one office distributed in the national territory to easily cover the displacements and thus save costs in logistics to our clients. We also offer monitoring with international coverage through alliances with other CROs or our own monitors, depending on the needs of the study.

Data management: State-of-the-art technologies to ensure the highest quality for your studies. Our platform complies with international legal requirements, is based on SAS and has been developed following the indications of the international GAMP v5 guide. The system we most commonly use is Openclinica, although we have also carried out projects with other systems at the request of the sponsor. We adapt the electronic data capture (EDC) system for any phase, therapeutic area or study size, ensuring the efficiency and security of data collection.

Medical Coding: Whether you need a standard dictionary or an ad-hoc solution for your medical coding requirements, we have a solution for you.

Biostatistics: We offer highly qualified, in-house staff to perform independent biostatistics consulting or statistical programming in our studies. We also work on diagnostic statistics with instruments that allow prognostication for early disease identification and treatment selection. We assist you in getting the best out of your data.

Mod&Sim PK/PD: Advanced solutions to make informed decisions about your drug development program and clinical study design. We develop pharmacokinetic and pharmacodynamic models, biostatistics and bioequivalence analyses that will allow you to reduce costs and time in your R&D activities, as well as the optimization of drug effects per patient.

Medical writing: This is the only service we currently outsource to our trusted provider, a company specializing in medical writing, with a large team of writers. We provide you with a team of professionals with extensive experience in medical writing, covering practically all therapeutic areas and clinical development fields. Among others, we facilitate the writing of: protocols, informed consents, final reports of clinical studies, articles and scientific publications. Professionalism, punctuality and quality are the cornerstones of our medical writing service.