Integrated solutions to accelerate your HealthTech product development process
Early-stage clinical development, typically encompassing Phase 1 and Phase 2 trials and presents several challenges, including:
- Patient population definition and subsequent recruitment
- Scientific uncertainly for a new MOA
- Regulatory compliance and disparities across development regions
- Resource constraints
- Competitive landscape
- Manufacturing challenges
- Endpoint selection and alignment between health authorities and varying standards of care across regions
- Data interpretation
Overcoming these challenges requires careful planning, collaboration among stakeholders, adherence to rigorous scientific and ethical standards, and sometimes, a willingness to adapt strategies in response to unexpected developments.
What we offer:
Our expert team is dedicated to accelerating your drug development journey with integrated solutions, from Phase 1 through Phase 2 trials. With a proven track record of success, cutting-edge technology, and a commitment to regulatory compliance; we are here to help you bring life-changing therapies to market faster and more cost-effectively.
- Protocol Development: Assistance in designing the clinical trial protocol, including study objectives, patient inclusion/exclusion criteria, and endpoints. CROs provide expertise in optimizing study design.
- Regulatory: Assistance with interactions with regulatory authorities, for example, a US pre-IND meeting, to ensure compliance with local and international regulations and achieving successful health authority submissions.
- Site Selection and Management: Identifying and selecting appropriate clinical trial sites, managing site contracts, and providing ongoing site support to ensure smooth trial execution.
- Patient Recruitment and Retention: Developing strategies to enroll and retain study participants, which is critical in early-stage trials with small patient populations.
- Clinical Monitoring: Conducting regular site visits to ensure data quality, patient safety and protocol compliance. This includes source data verification and adherence to Good Clinical Practice (GCP) guidelines.
- Data Management and Biostatistics: Collecting, managing, and analyzing clinical trial data, including the development of statistical analysis plans and generation of study reports.
- Safety Monitoring: Continuous monitoring and reporting of adverse events to regulatory authorities, as well as implementing safety protocols to protect trial participants.
- Quality Assurance and Auditing: Ensuring that all trial activities adhere to regulatory and GCP standards through quality assurance and auditing processes.
Why work with us?
Agile project management:
Overseeing all aspects of the clinical trial, including timelines, budgets, and resource allocation, to ensure that the trial stays on track.
Strong scientific and medical expertise:
Providing access to medical experts who can contribute to trial design, safety assessments, and data interpretation.
In-house interdisciplinary experts:
Our experts include scientists in the field of regulatory, CMC, market access and data management.
Cost efficiency:
We offer transparent cost structures and budgeting, ensuring you get the most value from your investment.
Expertise 
