Transforming ideas into research-ready clinical programs.

Our Scientific Advisory Team brings deep experience in concept development and study design for all clinical trial types — including bioequivalence, bioavailability, and proof-of-concept studies.

We start by understanding your scientific goals and product strategy, then collaborate with you to define clinical objectives, evaluate market potential, and assess feasibility.

Together, we develop tailored project concepts, timelines, and budgets that ensure clinical excellence, regulatory compliance, and operational feasibility — setting a strong foundation for your trial’s success.

Delivering clarity, accuracy, and compliance in every document.

Our Medical Writing experts — physicians and scientific professionals with clinical research experience — prepare documents that are consistent, scientifically sound, and fully compliant with ICH and regulatory standards.

We support every stage of your development program with high-quality medical and scientific writing, including but not limited to:

• Study Protocols and Amendments
• Informed Consent Forms
• Case Report Forms
• Clinical Study Reports (CSRs)
• Investigator’s Brochures
• Development Safety Update Reports (DSURs)
• Manuscripts, Abstracts & Scientific Presentations
• Indication and Protocol Training Material

Every document undergoes rigorous internal review to ensure accuracy, consistency, and alignment with your submission or publication goals.

Turning scientific outcomes into credible, impactful publications.

CORONIS provides strategic publication planning and scientific manuscript development to communicate your research effectively and transparently.

We help sponsors plan publication timelines, prepare abstracts, posters, and manuscripts, and manage submission to peer-reviewed journals or conferences.

Our medical writers collaborate closely with investigators and medical experts to ensure clarity, accuracy, and adherence to international publication standards (e.g., GPP, ICMJE).

Independent oversight ensuring safety and scientific validity.

CORONIS supports the setup and coordination of Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs) for clinical trials requiring independent safety and efficacy oversight.

We manage charter preparation, meeting logistics, documentation, and communication between sponsors and committee members — ensuring confidentiality, regulatory compliance, and transparent decision-making processes throughout the study.

Ensuring patient safety through vigilant monitoring and regulatory compliance.

Our medical team provides ongoing safety surveillance and adverse event (AE/SAE) reporting across all study phases.

We collect, assess, and report safety data in compliance with Good Pharmacovigilance Practices (GVP) and global regulatory requirements.

Activities include continuous safety monitoring, signal detection, expedited reporting, and preparation of periodic safety update reports — all managed with accuracy and medical insight.

Effective response systems to safeguard product integrity and reputation.

CORONIS provides structured support for managing product quality complaints (PQCs) and clinical crises.

Our medical and regulatory specialists assess, document, and report product quality issues in coordination with sponsors and regulatory authorities.

We implement corrective and preventive action (CAPA) plans to mitigate risk, protect patient safety, and maintain sponsor compliance and trust.

Reliable, responsive communication for healthcare professionals and patients.

Our Medical Information team manages inquiries from healthcare providers, investigators, and patients — ensuring that every response is accurate, balanced, and evidence-based.

We maintain detailed documentation, classify inquiries, and provide medically verified information aligned with product labeling and ethical communication standards.

Building collaborative partnerships with scientific and clinical leaders.

CORONIS supports the identification, engagement, and management of Key Opinion Leaders (KOLs) to strengthen scientific communication and clinical collaboration.

We facilitate productive relationships through advisory boards, investigator meetings, and educational programs — ensuring transparent, compliant interactions that enhance both study insight and brand credibility.