Preparation of Protocol Investigator Brochure (IB) or Product Dossier Case Report Forms (CRFs) Informed consent form (ICF) Subject Diaries Study logs (delegation log, IP logs, etc.)
Documentation of clinical trial (TMF, PMF, SMF ) Quality System Management Case Report Forms (CRFs) SOP Development
Preparation of Study Design Determination of sample size based on power analysis Interim Analysis Final Analysis & Report Clinical Data Management Both papers CRF and EDC Designing CRF Database development & maintenance Quality Control & Quality Assurance DCFs Generation/Resolving External data management Data entry and data processing
Ethics Committee registration (Under both DHR and DCGI) Renewal registration of EC (DHR and DCGI) Reconstitution of EL (DHR and DCGI) GCP Training for EC Members EC Registration Query Resolving. EC SOP Preparation
SMOconnect provides Quality Assurance audits to various sponsors to audit their Indian as well as Global studies. SMO connect Quality Assurance department consists of a team of experienced QA professionals who can perform on-site monitoring for clinical trials of all phases and can conduct pre-study audits of CROs, investigational site audits, Trial master file (TMF) audits, report audits and…
Site Level GCP – Schedule Y Training This training provides a brief review of new drug development, clinical trial process, Good Clinical Practice (GCP), relevant sections of the Code of Federal Regulations (CFR), International Conference on Harmonization (ICH), and Form FDA 1572 are discussed in-depth and in relationship to the investigator’s responsibilities for proper conduct of clinical trials.…
SMOconnect can provide full regulatory support tailored to your exact requirements. We provide support throughout the product lifecycle, from defining the regulatory strategy, facilitating meetings and discussions with the authorities, to clinical trial approvals, marketing authorization submissions through post-licensing support. SMOconnect also support the ethics committees for the successful submission and registration at CDSCO. SMOconnect extend close follow…
SMOconnect provides expert clinical data management services to our sponsors with consistent data quality from Database build to Database lock. We are committed to customizing data management solutions that emphasize transparency, integrity, and accountability as much as speed and accuracy. Our clinical data management team produces results that are source-verified, reproducible, and cost-efficient. Our data management systems comply with…
Clinical Trial Management The SMOconnect clinical operations team comprises qualified and trained people with extensive experience in managing phase I to IV studies for regulated markets. Our SOPs are well aligned with both regulatory norms as well as best practices of the industry. SMOconnect utilizes a streamlined project management model, providing a single point of contact to oversee…
Pre-clinical studies are also called Non-Clinical Studies usually performed in laboratories using cell culture models, animal models, and biochemical techniques. We have GLP-compliant animal houses to serve all your needs in preclinical studies. The services offered are as follows: Acute, Subchronic & Chronic Toxicity Carcinogenicity & Reproduction Toxicity Irritancy Studies Allergenicity Genetic Toxicology Field/Clinical Exposure Studies on…