Our Core services
- Monitoring
- Project Management
- Site Management(SMO)
- Medical Monitoring
- Medical Writing
- Regulatory Services
- Quality control and Quality assurance
Project Management
Our highly experienced Project Management will help Pharmaceutical, Biotechnology, Medical devices, Nutraceuticals, and Ayurveda companies, and CRO’s in choosing the right service provider and clinical trial sites.
Project Management in our mechanism ensures that collaboration is maintained on each function of a project to manage all its operational aspects and quality, in terms of minimized risks & clean data, is delivered efficiently & timely, as per the GCP
guidelines.
Clinical trial Site Management (SMO)
Our site management organization (SMO) department provides clinical trial-related services to Pharmaceutical, Biotechnology, Medical devices, Nutraceuticals, and Ayurveda companies, and CRO’s.
We are continuously expanding our therapeutic areas and number of study sites for conducting clinical trials within the given time frame.
We perform the listed key tasks that are required in the execution of patient-based clinical trials.
- Investigators and trial site identification
- Clinical trial monitoring
- Site activation
- Investigator & Trial staff training
- Trial execution at the trial site
- Trial site quality control and quality assurance
- Review of documents (paper/electronic)
- Communicating between client/sponsor and trial site
Monitoring
Well-proficient in FDA-regulations, ICH guidelines & GCP/SOP-compliance, our CRAs bring in strong monitoring & clinical experience for key therapeutic & specialized areas to provide quality & performance feedback, technical support, data-query resolution, source document-review & site management for various trials ( GCP, GLP, Medical Monitoring, Bio Studies review
Medical Writing
Our medical writers compile new facts, ideas, thoughts & perceptions on drug & device-discoveries, which are nothing but a well-structured information to different audiences, including patients, consumers, physicians, drug regulators and other healthcare experts.
We provide scientific medical writing services for the below-listed work.
- Writing and editing scientific documents
- Preparing clinical trial study documents, i.e. protocols, informed consent documents, CRF, patient diary, and investigator's Brochure.
- Preparing clinical trial regulatory submission documents, i.e. clinical study reports, clinical overviews
- Preparing clinical trial feasibility (by highly experienced subject matter experts)
- Literature search & providing literature search summaries
- Pharma-co-vigilance documents, such as Periodic Safety Update Reports
Regulatory Services
- Regulatory Dossier Compilation
- Regulatory approvals for Phases I-IV, devices studies and BE- Studies
- Approval of import license of drugs
- Safety Reporting
- We help in filing clinical trials applications with CDSCO (Sugam portal)
Quality control and Quality assurance
Our QA & QC teams perform reviewing and audits activities of every phase of the clinical trial.
Some of the activities but not limited to:
-Clinical trial site qualification
-Clical trial site QA/QC tasks
-Reviewing study paper CRF/eCRF (online/offline)
-Support in preparing response and giving suggestions on regulatory queries.