Contract Research Organisation (CRO)
Cadila CRO, Ahmedabad, India is an independent contract research organization operating since 2005.
We ensure with assurance, high quality, complete accountability and integrity, efficient datageneration and unbiased analysis, and interpretation of results. As well as timely delivery of project and tailor made solution for our sponsors result in utmost customer satisfaction.
Our CRO at A Glance
- Well established & experienced: Pre-Clinical to Clinical trial
- Highly qualified, experienced & professional scientists
- ICH-GCP trained clinical trial management team
- Wide network of hospitals & medical institutes
- Collaboration – DBT, DST & CSIR
- Highest confidentiality & integrity on every project
- Success – highly motivated, dedicated scientific personnel, well-define organizational structure with good leadership.
Offer complete package for phase-I to phase-IV studies
- CRF, ICF & Protocol Development
- Site development & management
- Site staff and Investigator’s training
- Clinical trial Monitoring & Project Management
- Data management & statistical analysis
- Experienced in various therapeutic area
- Medical Writing (Schedule-Y & ICH E3 Format)
Committed to conduct studies as per need of sponsor and applicable regulatory guideline
- Robust experienced in major therapeutic
- Prompt, responsible & competent team
- High confidentiality standard
- GLP & GCP trained experienced team
- Collaboration with medical & government
- Cost effectiveness with quality
- Tailor made solution with data integrity
- Efficient reporting system & reliability
- Utmost customer satisfaction
CPL Inc. through its parent company Cadila Pharmaceuticals in India extends efficient manufacturing for your products.
- Efficient & well-defined
- High quality standards & authentisity for every project
- Independent quality assurance team
- Experienced team with expertise
- Audit at every step along with internal facility audit
- Archiving facility with proper temperature & humidity controlled
- Assurance of compliance in final report
- Periodic training of employee to meet regulatory standard
Quality Assurances & Archive
- Dedicated, qualified, well trained & experienced QA team
- Regular system audits to facilitate continuous system improvements
- Conducting regularly internal CRO audits to ensure 100% data integrity
- Oversee inspections of various regulatory authorities
- Handle regulatory/sponsors queries & recommendations
- Automated temperature & RH control archival unit
Quality Standards certification
- Audited & approved by DCGI for the BA/BE centre.
- Audited & approved by WHO Geneva
- Audited & approved by ANVISA, Brazil.
- MoH, Turkey - Dossier submitted & accepted.
- MHRA - Dossier submitted & accepted.
- TGA Australia - Dossier submitted & accepted.
- MCC South Africa - Certification for the Dossier submitted.
Regulatory Audit update
|Regulatory Body||Type of Audit||Year||Status|
|DCGI, India||Facility based||2011||Compliance audit pending|
|WHO, Geneva||Facility based||2005||Passed|
|ANVISA, Brazil||Facility Audit||2004||Passed|
|ISO 9001:2000 and ISO 14001:1996||Facility Audit||2005||Passed|