Clinical Trials Solutions
Clinical Trials Study Design
We can design every aspect of your clinical trials. Our years of experience and knowledge combined with our medical animation resources, showcases your clinical trials in the best possible light. This maximizes your chances of acceptance with the FDA and EMA. In turn, this allows you to move forward with your clinical trials and product development plans.
Your clinical trials study design will:
- Outline the clinical trials design and description
- Show clearly the objectives of your clinical trials
- Make clear which patients are required for the study, their disposition, and how many
- Outline the important data sets that needs to be collected
- Make clear control measures to be used, and levels and methods of blinding/masking
- Ensure the efficacy and safety profile aspect is evident and clear
- Outline the methodology of your clinical trials
- Meet the requirements of the FDA/EMA including protocol design
- Data quality assurance used in your trials including statistical and analysis approach
- Utilize our medical animations to showcase your study
Your clinical trials will be put together by experienced professionals who can put together your clinical trials study to maximize acceptance with regulatory bodies.
You do not want your clinical trials aspirations faltering before it can get off the ground.
Engaging Stakeholders in your Clinical Trials
Fast Track the Inception of your Clinical Trials
Once your clinical trials has approval, we then put together medical animations for your stakeholders. This has several purposes, and thanks to the information being showcased in an easily understood manner, training and consent has a much higher success rate.
Using a combination of medical animation, cloud based web portals, apps, and direct messages we will:
- Showcase your clinical trials objectives to selected patients, maximizing the chances of consent
- Provide training information using medical animations to help stakeholders visualize how the trials will work
- Deliver necessary training to all participating clinicians
- Ensure the clinical trials is delivered in accordance with the trials objectives
- Maximize the participation of stakeholders
Given how important consent and clinician participation is to your clinical trials, our medical animations have been designed to appeal and engage all stakeholders.
Collecting your Clinical Trials Intelligence
Clinical Data Management and Biostatistics Solutions
As well as designing your clinical trials study and educating stakeholders on how it will work our bespoke statistical data management apps will collect your clinical trials data and hold it securely. As well as collecting your data, our systems integrate with your systems, turning your clinical trials data into meaningful information. The data collected will be in accordance with your clinical trials study design.
Our software will ensure that every information aspect is collected over the course of your clinical trials. This includes but is not limited to the following:
- Descriptions of data quality assurance and control measures used in your trials
- Statistical and analytical plans
- Laboratory biostatistics including all aspects of individual patient data
- Dropouts or missing data reporting
- Multiple comparisons/multiplicity
- Efficacy and safety measurements assessed
- Changes occurred during the study or planned analysis
- Reporting in necessary formats as per clinical trials guidelines and requirements including graphs, flowcharts, tables, and written reports
Our statistical data management solution ensures your clinical trials intelligence is usable, accurate, and provides the information you need to make decisions to take your project forward.
Clinical Study Reports
Professionally Written Clinical Study Reports
Once a clinical trials study is complete and the information collected, we can write your clinical study report showcasing what you have discovered, including the important data and evidence needed for a professional and thorough CSR.
This includes but not limited to the following:
- Overall study design and description
- Control groups used
- Patient criterion and individual clinical trials patient data
- All aspects of treatments administered including dose and timings, treatment compliance, method of assigning treatment groups, and blindings
- Efficacy and safety variables and data collected from the trials
- Data quality assurance and statistical methods used in the protocol and determination of sample size
- Changes in the conduct of the study or planned analysis that occurred during the clinical trials
- Information presented in tables, graphs, figures, flowcharts, and text in line with regulatory body requirements
Your clinical trials report has to meet a complicated criterion and ascertain certain standards. We can take care of this stressful aspect, presenting the report in accordance with regulatory body requirements.
To use our services simply complete the Manage my Clinical Trials Form, and we will contact you within 24 hours.