|We design clinical trials to explore new scientific evidence and benefits, confirm health outcomes and substantiate claims.|
Safety and toxicology evaluation
Toxicological evaluations are required to demonstrate the safety of a product or its components.
From the early stage of product development, SPRIM ADVANCED LIFE SCIENCES may provide a wide range of in silico / in vitro / in vivo / ex vivo assays and animal models for product testing during:
- general toxicology studies;
- genotoxicity studies;
- immunotoxicology studies;
- biocompatibility studies;
- developmental and reproductive Toxicology studies;
- phase I clinical trial.
SPRIM ADVANCED LIFE SCIENCES canprovide customised pre-clinical solutions for preliminary data collection with its pre-clinical development offices around the world, as well as providing a unique network of GLP certified global R&D laboratories.
For more information on safety and toxicology evaluation please contact us
Non-human efficacy testing
Non-human efficacy evaluations provide information related to a product or its component performance. In addition, they can provide some information related to kinetic properties, route of administration, absorption and elimination of the molecules.
SPRIM ADVANCED LIFE SCIENCES can provide customised pre-clinical in silico/in vitro/ in vivo/ex vivo and animal model tests by supporting product development right from the initial stages of the process:
- Animal models, including genetically engineered animal;
- In silico/in vitro/ex vivo/in vivo preliminary efficacy tests;
- Bioanalytical analysis services;
- Kinetics and product metabolism evaluation;
- Bioavalability and bioequivalent assessment.
For more information on non-human evaluation please contact us
Human efficacy testing
Interventional studies are often conducted in laboratories and clinics to mainly establish the safety and efficacy of an investigational product. SPRIM ADVANCED LIFE SCIENCES can conduct mono and multicentric cross-country clinical trials all over the world with the identified target population (healthy, sub-healthy and diseased subjects) and rapid and effective processes in the fields of:
- Product absorption, distribution, metabolism and excretion (ADME) studies;
- Product efficacy studies;
- Prophylactic product studies;
- Diagnostic product studies;
- Surgical procedures studies.
We currently conduct global Phase I-II-III till Post Marketing studies. Utilising our expertise, we directly interact with our partners and clients, designing the best strategy of trial implementation. This includes cross-over design, parallel controlled randomized design allocating the double-checked statistical outcomes for a minimised, blocked or stratified randomisation process.
Our project planning team can provide smart solution in study outline development, protocol design, definition of objective and outcomes, as well as coordinating the implementation thanks to the expertise of our global and local team.
With our extensive clinical development experience, we are able to offer our clients appropriate allocation of resources, innovative strategies and tools to bring commercial insights into clinical development. This results in more efficient studies for our clients, meeting their needs and providing higher quality data to help improve products’ success in the marketplace.
Ten years of experience in the field of clinical trial design and implementation allows us to provide a complete research solution or specific service to realise a tailor-made research programme:
- Strategic patient recruitment service: we offer innovative, customized services for patient recruitment needs. Our unique services include the development and optimization of effective advertisement campaigns and enrollment strategies strictly following ethical principles and country based legislations. Slow patient recruitment is by far the most common cause of delays in clinical studies. We use a well-defined process when selecting sites to ensure a high probability of reaching the required number of patients for the study within the specified timeline.
- Medical writing support: our team of dedicated, professional medical writers can provide a complete writing service to clients around the globe, spanning the generation of individual documents to extensive medical writing programs. We ensure that the medical writer assigned to each project team has the required document and health area expertise to fulfill each sponsor’s needs. A complete medical writer service: we are able to follow your activity from synopsis and protocol finalization, to clinical report and peer-review journal study publication.
- Regulatory and ethics committee submissions and contacts: a solid regulatory plan can help you conduct the right studies at the right times, attain regulatory approval sooner, and, ultimately, market your product sooner. We have many years’ experience of handling the regulatory and ethics committee submissions and contacts at the global level. Our knowledge of local ethics and regulatory requirements is invaluable in reducing approval process timelines.
- Clinical monitoring and site management: thanks to our global network of clinical research associates and the advanced informatics tools in place, we can perform standard on-site Monitoring activities as well as in house remote data monitoring. Our project teams collaborate closely with our sponsors, and maintain close contact with the sites, supporting each investigator in order to maximize study quality and performance.
- Study management: comprehensive project management is the key to the success of any study. We have teams of experienced project managers present all over the world. Our project managers maintain an overview of all aspects of the study, working closely with the study team to ensure control of project scope, quality, budget and timeline.
- Biometric support: a well designed statistical analysis plan improves the quality of clinical trial reporting and raises confidence in study findings. Our biostatisticians understand the subtleties of study design and statistical techniques such that the trial can be designed and optimized for success while, at the same time, balancing timelines and budget constraints. Whether it’s sample size calculations, study design development, statistical analyses, or data interpretation, Sprim can tackle even the most complex projects and deliver fast, accurate, and cost-effective solutions.
Post marketing evaluation
As a requirement for the approval or continued marketing of products, post-marketing and regulatory commitment studies may provide our partners with additional helpful information regarding product improvement by seeking to maintain the already acquired marketing segment or enlarge it by enhancing the intrinsic and scientific value of their own products.
Safety and Surveillance Studies
Monitoring the safety of products for human use is a key concern throughout the product’s lifecycle in order to provide evidence of its beneficial effects.
SPRIM ADVANCED LIFE SCIENCES identifies the best safety assessment protocol design and the key parameters to be tested to ensure product safety and tolerability in the human body. Also evaluating the known safety issues for both the short and long-term safety profile of a product.