Clinical Operations
Clinical Operations
We Deliver The Best

We, with our dedicated team of Clinical Operations experts carryout phase trials, BA/BE, observational studies and what not!

Study design and development

Every study that comes to our door, is designed with utmost care and rigorous discussions. Our team of experienced Medical Advisors, Biostatisticians, Clinical Operations experts and epidemiologists make sure that the protocol is accurate and is apt to answer the scientific question that has been posed. Our study startup team ensures effective protocol design and development and assist you in each and every aspect. Our study design and development services include

  1. ● Protocol Development
  2. ● Review of the protocol
  3. ● Informed Consent Document design and development; and its translational and back translational services
  4. ● CRF Designing and development
  5. ● Study design and its execution plan
  6. ● Site selection and subject recruitment plan
  7. ● Development of statistical plan
  8. ● Planning and conduction of Investigator meetings

Project management

Quality execution of the trial being the promise that we make to our clients, our team strives and works towards achieving it. Coordination, collaboration and communication being the key to efficient project management, we make sure each member of the team is well equipped with these skills.

  1. ● Site feasibility and start up
  2. ● Effective strategies for subject recruitment and retention
    1. * Appropriate site with required patient pool
    2. * Strong referral network
    3. * Real time data and analytics experts for efficient subject recruitment
    4. * External database
  3. ● Adherence to timeline
  4. ● Accurate documentation
  5. ● Adequate training for all the staff involved
  6. ● Efficient contract and finance management

Site Management

If you are looking for site management services with the most proactive approach then you are at the right place! Yes, we at Samahitha, have an extraordinary team of experienced Clinical Research coordinators and assure to provide you the best site services you can ever experience. Our site management services include.

  1. ● Assistance in Site feasibility assessments and site contracts
  2. ● IRB submissions and approvals
  3. ● Assist the PI in subject recruitment and retention
  4. ● Assist PI in maintaining the Site Master File
  5. ● Coordinating and scheduling subject visits
  6. ● Drug accountability and dispensing
  7. ● Effective maintenance of study related logs
  8. ● Effective followup with subjects
  9. ● Assist CRA during monitoring visits
  10. ● Drug and sample shipment
  11. ● Study subject payments
  12. ● Assist in Data entry, resolution of queries and AE/SAE reporting

Clinical Monitoring

A well-reviewed trial yields results that are near to accuracy! Our dedicated team of Clinical Research Associates gives you the best monitoring services for your trials. We focus on risk based monitoring and believe in perfection in our work. Our trial monitoring services include.

  1. ● Site Identification and feasibility assessment
  2. ● Collect, review and process the Essential documents
  3. ● Complete monitoring services: Qualification, Initiation, Interim and Close-out visits
  4. ● Reviewing Eligibility criteria and proper documentation of Informed Consent
  5. ● Thorough review of Data collection
  6. ● Source Documents and CRF Verification
  7. ● Reviewing Site documents
  8. ● Reviewing on time reporting of AEs/ SAEs
  9. ● Effective mediation between the site and our organization
  10. ● Ensuring safety, regulatory and other necessary compliance
  11. ● Effectively training all the study personnel
  12. ● Ensuring trial completion with minimized deviations and no violations
  13. ● Review of accountability
  14. ● Oversee accurate logging and documentation
  15. ● Ensure compliance and implementation of study protocol
  16. ● Study close out and Database lock
  17. ● Completion of visit reports within the timeframes