Professional Documentation and Procedure Services
Accuracy and deadline assured
Our professional solutions ensure that your projects are developed faster and with precision. The development of documentation and protocols are extremely important, and our fifteen years experience in the field has given us the insight to develop these faster and more accurately.
Freeing up your time to concentrate on other important aspects of your clinical trials and drug development projects.
Make your Teams more Agile and Concentrating on Drug Development
Utilizing a vast selection of sources, our bibliographical search solution will collate all the data you need for your drug / device /biologic project to come to life. This important and onerous step of project development can be outsourced to our clinical data teams. Relieving the pressure on your shoulders, and enabling your teams to perform with more agility in the development of your project.
Our service fulfils Modules 2.4, 2.5, 5 and 5 of the following:
- Pre-clinical data Overview of the nonclinical testing strategy Pharmacology Toxicology
- Clinical data Product Development Rationale Clinical Pharmacology Safety Efficacy Benefits-Risks Conclusions
- Non Clinical Reports
- Clinical Reports
Using our Medical Writing services you will have first class documentation on important aspects of your projects. This will ensure compliance on all levels.
Our medical writing services feature clinical and regulatory submissions which are in line with compliance, local regulations, and ICH guidelines. Given that we have been doing this for fifteen years, often our medical writing brings levels of expertise which exceed client expectations and capabilities.
Our regulatory and clinical writing expertise extends to these areas:
Regulatory and Clinical Writing
- Report writing in compliance with ICH E3 guidelines/applicable regulatory submission
- Clinical study report appendices
- Case report forms.
- Investigator Brochures Briefing/meeting packages
- Clinical development plan
- Top-line results report
- Informed consent form
- Site specific and country specific reports
- Drug, device and biologic marketing applications
- Slide presentation
Precise and accurate medical writing not only saves time, but considerably increases your chances of success.
Standard Operating Procedure Development (SOP)
Our SOP solution approach is to develop bespoke plans which take into account your clinical operations, clinical monitoring, feasibility, and project management. This enables us to identify the crucial areas and build from that point.
With a SOP developed in a timely fashion, your projects get underway faster and more easily directed as you have a tangible SOP to work to from the outset.
Typical SOP development projects include but are not limited to:
- GCP Training
- Subject Screening and Recruitment
- Informed Consent Process and Documentation
- Eligibility Confirmation
- Source Documentation
- Data Management
- Protocol Deviations
- Adverse Events and Serious Adverse Events Reporting
- Confidentiality of Information
- Drug/Device Storage, Accountability and Management
- Regulatory Document Submission Process (Initial Submissions, Amendments and Continuing Reviews)
- Sponsor, Intellect and Internal Audits
- FDA Audits
Using our SOP Development solution you will have a basis to move your project forward faster, as your teams will be better informed and directed.
Case Report Form Design Solution
Our Clinical Data Handlers bring their fifteen years experience to your project, and design case report forms which both support and enhance how your record data in your projects. At all times any form we provide will adhere to the following standards:
Collect data relevant to the specified protocol
The CRF design process is fully documented including approvals and version control
The CRF will be available at a specified clinical site prior to the enrolment of a subject
This includes full training given to your teams on protocol, CRF completion instructions, and data handling procedures. The training is fully documented so it is clear to managers who and who has not received it, and will be complete before subjects enrol
Through using our fifteen years experience to create a comprehensive CRF, you will have everything in place and ready to go prior to your first subject enrolling.
Protocol Design Solution
Outsource protocol design for us to ensure success and speed
Protocol design development for your clinical trials are fundamental in development of the project. Our services have been designed with this in mind and provide an accurate and bespoke designed protocol to ensure the progress into the clinical phase of drug development runs smoothly.
- Protocol conceptualization, designing and preparation in compliance with ICH GCP guidelines.
- Study laboratory manuals to accompany the clinical protocol
- Comprehensive sub-study protocol design and implementation
- Informed consent form design and Patient Brochures
- Case report form design
- Clinical and non clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU or US Regulatory Authorities
- Your protocol can be written in English or French
Our knowledge of clinical pharmacology, combined with our scientific and clinical approach will ensure you easy transition to the clinical phase of drug development.
In all instances complete the Make my Documentation Professional form.