Main Services Overview

SMOconnect facilitate high quality clinical trials across the globe with our wide network .As an integrated clinical development service provider, we continuously focus on providing innovative approaches for planning and conducting clinical studies across all phases of development within a framework of competitive budgets and efficient execution methodology.

We are efficient and successful in bringing a powerful combination of regulatory, scientific and clinical expertise with business finesse to help our clients succeed in their clinical development programs to launch their products to the market in an efficient and cost-effective manner. This makes us unique from other companies.

Services List

Preclinical Studies

Pre-clinical studies are also called as 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, Sub chronic & Chronic Toxicity
  • Carcinogenicity & Reproduction Toxicity
  • Irritancy Studies
  • Allergenicity
  • Genetic Toxicology
  • Field/Clinical Exposure Studies on Human Volunteers and Livestock

Clinical Trial Management

The SMOconnect clinical operations team comprises of 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 the people, processes and operations.

We are committed to meeting the client’s needs for quality, compliance and agreed upon delivery times in order to achieve and, where possible, exceed the target plan with the guarantee that all work is carried out in accordance with SOPs, GCP/ICH guidelines and applicable regulatory requirements.

Site Management

We help the hospitals to set-up a Clinical trial Unit (CRU) for managing Clinical trials. SMOconnect is working with 50 Multispecialty Hospitals and 10 Medical Colleges hospitals across South India and is conducting trials in all major therapeutic area.

Pre – Trial Activities

  • Identify potential GCP trained sites / Principal Investigator.
  • Provide GCP training to PI & study team at a regular basis.
  • Provide GCP trained Clinical Research coordinators for every site.
  • Identify and coordinate preparation & submission of essential documents to CRO/ Sponsor.
  • Ethics committee submission & approval with turn-around time.
  • Site set up & essential document preparation.
  • Create source document template if applicable.
  • Prepare site for Site Initiation Visit.
  • Pre-screening/ pre-identify cases for competitive trials
  • Planning Recruitment Strategies

During the trial

  • Assist the Investigator in the ICF process, screening & enrollment.
  • Implement recruitment strategies
  • Maintain source documents in guidance with Investigator team.
  • Completion of CRF/ eCRF with in specified timelines
  • Maintain and update Trial Master File.
  • Dispense Investigational product & maintain drug storage & accountability as per the requirements.
  • Coordinate Central Lab logistics & sample flow.
  • Coordinate subject follow-up visits & preventing lost to follow up
  • Coordinate subject reimbursements.
  • Coordinate Monitoring & Audit visits.
  • Coordinate SAE reporting on time maintain documentation.
  • Coordinate and maintain the ethics committee documentation during the study.

Post trial activities

  • Coordinate close out visit
  • Resolve data queries on time in coordination with Investigators
  • Archival of Data
  • IP Destruction

Clinical Data Management

SMOconnect provides expert clinical data management services to our sponsors with consistent data quality from Data base build to Data base 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 are in compliance with FDA 21 CFR Part 11 and industry guidelines for managing data.

Our services encompass:

  • CRF design, printing & distribution
  • Database design & setup
  • Edit checks programming
  • Double data entry
  • Data validation & discrepancy management
  • Medical coding
  • SAE reconciliation
  • Integration of third-party data
  • Database lock & archival

SMOconnect’s experienced, and result oriented team executes the management services in multi therapeutic areas of varied study phases. The team is equipped to provide solution in all platforms preferred by the sponsor.

TRAINING

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. This training will highlight the 13 principles of ICH GCP as the foundation for all clinical studies. We demonstrate the investigator and the site staffs about the basic requirements procedures throughout the clinical development of an investigational drug.

Objectives

  • To educate the Investigators in ICH GCP and other applicable guidelines
  • Describe the elements involved in the clinical trial process
  • Apply the principles of ICH GCP to current clinical trials
  • Examine the investigator’s responsibilities in the conduct of clinical trials as required in the regulations (CFR) and guidelines (ICH)
  • Guiding the investigators to perform clinical trials according to the respective guideline and ethics.

Who all can attend?

  • New Principal Investigators
  • Seasoned Principal Investigators interested in reviewing responsibilities
  • Sub-Investigators
  • Physicians interested in participating in clinical research
  • Site Researchers
  • Study coordinators
  • Ethics Committee Members

Regulatory Affairs

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 up from submission till the registration done in minimum course of period.

Please email your queries to info@smoconnect.com with subject EC registration.

Quality Assurance and Audit

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 system audits, to ensure compliance with Good Clinical Practice (ICH-GCP), FDA and local regulatory standards as a part of clinical trial services.

Internal systems audits include a comprehensive review of procedures and processes followed in the management of clinical trials.

EVENTS