Clinical Trial Project Management
Our dedicated project management team & their expertise and insights to help customers optimize the value of their drug development.
Our project management team are committed to provide up-front client-centric planning, from starting of study set-up to study closeout activities and all medical writing facilities.
medical writing
Site Development
- Site short list services
- Site selection
- Site infrastructure development
- Site Training
- Site Qualification
- Site related all activities
site development
Scientific Writing
- Clinical Development Plan
- Investigator Brochures and annual updates
- Protocols
- Informed consent forms
- Clinical study reports
- Clinical Management
- Clinical sections of CTDs
- PSURs & other pharmo-vigilance documents
- Preclinical study reports, expert reports and summaries
- DSMB manuals
- BIO analytical reporting
services
Regulatory Services
The independent team for reagulatory services helps you navigate complex regulatory requirements throghout your products development lifecycle.
Our Services include but not limited to:
- Support on indian regulatory requirments
- Compiling dossiers
- Executing regulatory submissions
- Safety reporting
- Preparation & submission of complete range of regulatory documents for obtaining approval:
- To conduct clinical trial in India
- To import licence of Test Drug & renewal
- To export Biological Samples
assurance & compliance
Quality Assurance & Compliance
We commited to high quality standards in all area of our operations. we conduct projects and activities efficintly and in accordance with international quality standards, best practicies and ethical principles to ensure that all operations and project adhere to local and international regulatory requirments and guidlines(ICH-GCP & Indian NDCT Rules 2019).
- Site Audits
- System | Process Audits
- Database | Vendor Audits
- Study document reviews
- GCP compliance review
- Drug accountability reviews
- Internal audits for SOP compliance
- IRB | EC audits
- On-site investigator audits
- Document Audits(Protocol, Clinical Study Reports & essential Clinical Trial Document)
data management
Clinical Data Management
Our Clinical’s Data Management team has valuable experience working with global and domestic sponsors and renders well timed, accurate, highest standard clinical trial data, helping you to make prompt and more effective decisions with regards to the safety, tolerability and PK | PD properties of your compound
clinical education
Training & Education
- ICH - GCP & NDCT Rules (2019) - Training
- Clinical Research Coordinator(CRC) Certification Course
- Clinical Research Associate(CRA) Certification Course
- Certificate course in Pharmacovigilance
- Prinicipal Investigator Training and Course
- Research Ethics Committees Training
100k
Satisfied Patients
5+
Health Sections
25+
Kinds of Research
5+
Award Winning
Daily New updates
Blog Updates
Holistic healthcare resort center
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Where Healthcare Science ans Nature Meet. The heaven for healthcare. Holistic Health Care Resort center
Corporate health program
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Corporate Health Programs are including three contains1. Policies and Program Development2. Programs3. Maintenance / Quality...
How a drug moves through clinical trials
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There are two types of clinical trials 1. Pre-Clinical Trial Phases 2. Clinical Trial Phases
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Live attenuated Vaccine, Inactivated Vaccine, Replication Viral Vector Vaccine, Non-Replication Viral Vector Vaccine, DNA Vaccine,...
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What people say
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Great Dentist if you need your family member to get effectiv immediate assistance, examination , emergency treatment o simple consultation. Thank you.
The Richads,12 Main Road
Great Dentist if you need your family member to get effectiv immediate assistance, examination , emergency treatment o simple consultation. Thank you.
