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Contract Research

a. Investigator selection

Choose from our wide database of experienced investigators specialized in diverse core therapeutic areas. We will work with sponsors to match a clinical trial with the best suited investigator based on need, quality and interest, and ensure complete commitment to achieve study outcomes.

 

b. Site feasibilities

We firmly believe that accurate initial feasibility assessment is a key factor in the success of a study with on-time enrolment and completion within budgets. Our scientific and clinical trial experts will conduct site feasibility checks including identifying, screening and qualifying investigative sites to meet the clinical trial requirements. Our established relationships with investigators and investigative sites across the country allow us to rapidly collect feasibility data and determine the best fit for your clinical trial. We strive to ensure timely and efficient conduct of the trial, without compromising on l trial objectives.

 

c. Site selection

Our skilled medical and clinical research professional team will work with the sponsor to appraise the sites with respect to protocol requirements, enrolment capabilities, costs and potential issues that may affect recruitment, conduct and/or patient retention and provide inputs for final site selection by the sponsor.

 

d. Clinical Trial Monitoring: Initiation, interim and study closure visits

We work with sponsors and investigative sites to ensure effective and efficient study visits. Utmost care is given to ensure compliance with follow up visits.

 

e. Regulatory document review, collection and processing

Our regulatory team works with sites for submissions and processing regulatory documents in compliance with ICH-GCP and Schedule Y guidelines, and ensure that all submissions are done in a time bound manner

 

f. Obtaining local ECs and IRBs approval

Our site staff coordinates with sites and local ECs for approvals of clinical studies, including submission, query resolution and follow up notifications of study updates

 

g. Site GCP, mentoring and training visits

Our proficient CRAs work to assure compliance at site to deliver high quality data and ensure subject safety. Motivation and training to maximise patient enrolment and retention are key parameters of focus in ensuring optimum trial conduct.

 

h. Carefully instituted corrective and preventive action (CAPA) plans

Our staff is trained for early identification of emerging issues and potential solutions to ensure regulatory compliance of the study. We follow diligent documentation and prompt implementation of remedial actions.

i. Data flow

One of our goals is to ensure timely delivery of CRFs for an efficient database lock for timely completion of the study.

 

j. Blinded and unblinded clinical trial material accountability

Our trained CRCs ensure clinical trial IP and material accountability with detailed documentation.

 

k. Facilitating communication flow

Frequent and clear communication with sponsors and sites is key to the success of a clinical trial. We establish an efficient system of communication for regular tracking of study metrics at the site.

 

l. Subject recruitment oversight

Subject safety is foremost in clinical research while meeting the accrual goals. Our staff is trained to navigate these twin goals, while adhering to the highest standards of GCPs.

 

m. Study progress monitoring at site

Our clinical operations team undertakes frequent visits and communication with investigative sites for updates on study progress, and to identify potential issues and provide solutions.

 

n. Mass mailing and newsletters

We arrange to provide regular study updates to all participating sites via mailings and newsletters to sustain the interest and commitment to the study.

 

o. Preparing sites for audit

We work closely with the investigator sites and sponsors to prepare the site for regulatory and independent inspections and audits – ensure correct documentation and communication.

 

Investigational sites

a. Study feasibility

We assist investigational sites and investigators to assess and evaluate study protocol for feasibility. Our medical and clinical research professionals work with investigators to prepare accurate and comprehensive study feasibility reports, and identify potential problems likely to impact study execution. Our aim is optimal development of your clinical research program.

 

b. Quality assurance in clinical trials

Our quality assurance team prepares site specific SOPs for the conduct of clinical research study and train the staff in implementation and provide continuous support through study cycle.

 

c. Investigator management

Study investigators are the most important link in clinical studies. Our experienced and knowledgeable staff understands the complexities of managing investigators to achieve target enrolment and deliver high quality data.

 

d. Patient database preparation

We provide services for preparation of patient databases and identifying study specific potential subjects for recruitment and enrolment.

 

e. Site staff support and management

Our pool of CRCs , data entry operators and field staff are trained in ICH-GCP, ICMR guidelines for clinical research and Schedule Y guidelines for clinical studies to provide the best in industry clinical research services. We provide continuous staff support throughout study period to make certain consistency and quality of the study.

 

f. Training programs

We bring the best clinical research professionals to conduct training programs in Ethics in Clinical Research and Good Clinical Practices in Clinical Research for all levels of site staff. We work with sites to customize the training programs to meet the needs.

 

Sponsors

We provide end to end trial management services for sponsors to meet their requirements for phase I-IV studies with the option to choose standalone services or package of services.
a. Study feasibilities
b. Investigator selection
c. Regulatory submissions
d. Study document translation and back translations
e. Site management to ensure GCP compliance
f. Coordination for data management and study completion procedures
g. Provide knowledgeable and trained staff for sites

 

Clinical Trial Execution

1. Randomization / Blinding / Languages Translation Services
2. Clinical Biostatistics
3. Clinical Data Management
4. Phase I/IIa and Early Clinical Trials
5. Phase II/III Clinical Trials
6. Clinical Monitoring
7. Late Phase Clinical Trials / Post Marketing Studies

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