Services
CRO Qualifications
We offer CRO Qualification services which can help the clients across the globe, range of Qualification services.
Our qualified, trained, and experienced Auditors shall perform the Qualification Audit as per GCP, GLP, GMP, and other regulatory requirements.
Our team is capable to qualify CROs (Pre-Clinical and BA/BE), Investigator sites, and Contract Manufacturing Organizations (CMO).
Qualified significant number of CROs for domestic and international clients.
Clinical Manpower Services
We offer clinical manpower services which can help the CRO for better commitment regarding trial with quality output.
Clinical manpower includes physicians, staff nurse, phlebotomist, study custodians and other relevant manpower.
Our people are trained on GCP, GLP, GMP, 21 CFR Part 11, Data Integrity, ALCOA, ALCOA+ and other regulatory guidelines and committed to do quality work.
For-Cause Audits
We offer for-cause audits services which can help the contract research organizations, clinical research organization and pharmaceutical industry for better commitment with quality output.
Our expert team shall analyze the high risk area and crucial processes, where chances of errors are high and Identification of problem/errors which led to failure.
Complete assessment of the risks and errors.
Application of the different systemic techniques to find out root cause. Designing way forward to become less or stop problem happening again and again to become refined and stable.
GAP Assessment Audits
We offer GAP assessment audits services which can help the contract research organizations, clinical research organization and pharmaceutical industry plants for better commitment with quality output.
Our expert team shall do Complete evaluation of system and documentation to identify the Gaps, risks and loopholes.
Our expert team shall collect the data from variety of sources depending on what’s being analyzed, such as by looking at documentation, brainstorming and observing project activities
Providing reasonable and logical solution to cope up the GAPs.
Making system in compliance to regulatory requirements by minimizing risk and GAPs
GCP, GLP and GMP Training
We offer GCP, GLP and GMP Training to the contract research organizations, clinical research organization and pharmaceutical industry by experts.
Clinical Translations
We offer various clinical translation services to our clients.
Our motto is to provide clinical translation services for clinical research organizations (BA/BE CROs), clinical sites (Investigator sites/Clinical Trial Centers), site management office (SMO), hospitals and pharmaceutical industry.
Our qualified, experienced team will do the translation and back translation of informed consent documents, patient information brochure, standard operating procedure, manuals, investigator brochure, recruitment materials like pamphlet and etc., as per applicable regulatory requirements and industry practices.
Project management & consultant services
We offer project management & consultant Services to the contract research organizations, clinical research organization and pharmaceutical industry.
We are capable to provide complete end to end services for both BA/BE and clinical trials studies as per the client requirements.
Consultant Services shall be done for all relevant areas which includes (but not limited):
- BA/BE and Clinical trials studies
- CDISC services
- Quality management establishment
- Business development
- Other relevant areas
Clinical study monitorings
We offer various clinical study monitoring services which can help the clients across globe, rang of monitoring services.
Our qualified, trained and experienced monitors shall monitor the clinical study monitoring for Bioavailability/Bioequivalence (BA/BE) studies and clinical Trail.
Our team has monitored more than 2000 BA/BE studies and significant number of clinical trial studies.
Bioanalytical study monitorings
We offer various bioanalytical study monitoring services which can help the clients across globe, rang of monitoring services.
Our qualified, trained and experienced monitors shall monitor the bioanalytical study activities.
Our team has monitored more than 1500 BA/BE studies and significant number of clinical trial studies
CRO qualification audits
We offer CRO Qualification services which can help the clients across globe, rang of qualification services.
Our qualified, trained and experienced auditors shall perform the qualification audits as per GCP, GLP, GMP and other regulatory requirements.
Our team is capable to qualify CROs (Pre-Clinical and BA/BE), investigator sites and contract manufacturing organizations (CMO).
Qualified significant number of CROs for domestic and international clients.
Audits for clinical and bioanalytical studies
We offer various clinical and bioanalytical study auditing services which can help the clients across globe, rang of auditing services.
Our qualified, trained and experienced auditors shall audit the clinical, bioanalytical, pharmacokinetic and statistical for bioavailability/bioequivalence (BA/BE) studies and clinical trial studies.
Our qualified, trained and experienced auditors shall do system & facility audits, site feasibility/qualification audits, regulatory compliance audits, GAP assessment audits, for-cause investigation and pre-inspection audits.
Our team has Audited more than 1000 BA/BE studies and significant number of clinical trial studies.
Talent acquisition services
We offer talent acquisition services to the contract research organizations, clinical research organization, and pharmaceutical industries.
Our talent acquisition team shall support entry, mid and senior levels to the contract research organizations, clinical research organization, and pharmaceutical industries.
We offer a formal training for the fresher in GCP, GLP and GMP by the experts.
CRO cardiology and radiology services
We offer cardiology and radiology services to the clinical research organization for better assessment of ECGs and X-Ray report of volunteers/Subjects.