Regulatory Submission Support

CLINICAL TRIAL REGULATORY SUBMISSION SUPPORT

Successfully align your clinical trial development with latest regulatory requirements by receiving our expert submission support across major therapeutic areas

Let our expert advisory team guide the documentation process to ensure strategic and operational regulatory submission

Highlights

AI Utilization

Increase study efficiency with AI to detect data entry errors in the study

Intelligence

Regulatory affairs success and clear proficiency in data standardization and submission models

Optimization

Accelerate time to approval and cost-saving services

Clinical Trial Regulatory Submission Support

As an experienced service provider, Sqilline offers complete management and successful submission of your regular documentation. Our regulatory professionals have the experience and knowledge to support your needs throughout the entire process in a wide range of therapeutic areas and indications.

Submission Preparation

Review and research all phases of the regulatory documentation process
Coordinate application filings to regulatory agencies

Submission Publishing

Ensure documentation compliance
On-going management and always staying ahead of all latest regulation changes

Use Cases

Sponsors

Traditional patient enrollment for clinical trials is a challenge. Enrollment processes consume up to 40% of the industry’s clinical trial budget and sponsors often struggle to identify the most suitable sites and to enroll the target number of patients.
Danny eClinical Research Platform integrates, structures, and analyses RWD from EHRs and provides powerful tools to select in real-time the right investigational sites and eligible patients who match the study criteria. Timely enrollment and quality of data are key for conducting cost-effective, high-efficient clinical studies. We speed up R&D in medicine to improve patient access and outcomes through technology.

Investigators/ Researchers

Currently, researchers have poorer efficiency with ill-timed and non-reliable digital medical records for patients who may be involved in a clinical study. Danny eClinical Research Platform provides sophisticated mechanisms for precise selection of patients to improve study compliance. Overall optimization of investigators' time for clinical trials, medical publications, and study analyses. Digitalized and structured medical records support informed clinical decisions and evidence-based treatment plans for better patient outcomes.

Patients

Patient access to innovative and effective health technologies could be lifesaving. Clinical trials very often provide treatment opportunities for the patients when all the other options have already been exhausted. Danny eClinical Research Platform supports the enrolment of all eligible patients in the investigational site not leaving a single patient behind.