Our services
Lifzneed offers professional support and real-time assistance to investigators and study sites, thereby enhancing the quality of studies, streamlining project timelines, and promoting standardization in clinical trials. Its non-medical judgment work in clinical trials ensures optimal performance, thereby contributing to the success of global sponsor(s)/CRO(s).
Clinical Trial Related Services to..
Contract Research Organization (CRO)
Medical Device Company
Pharmaceutical Company
Biotechnology Company
Site Management services include:
Site feasibility and selection
Lifzneed's local knowledge and on-the-ground teams enable us to maintain close contact with investigators. Our teams have established relationships with investigators, which we fully leverage during the feasibility process and throughout the study.
Our strong and established relationships with experienced investigators facilitate timely and comprehensive feasibility assessments, ensuring that the most appropriate and effective recruiting sites are selected for our sponsor's projects. At Lifzneed, we provide assistance to sponsors during site feasibility assessments, identifying potential sites for a particular therapeutic area and suitable investigators for a specific indication.
We work closely with Principal Investigators to ensure a thorough understanding of the feasibility questionnaire through discussion and available records. This helps to ensure that accurate information is provided, which in turn helps to prevent poor enrollment if a site is selected. We take utmost care in suggesting the right investigators from the site to the sponsor to achieve projected enrollment and data quality
The Site identification & investigator selection is done based on following points:
Patient Load | Investigator’s qualification and interest | Hospital infrastructure and resources | Papers published by the Investigator | Complete site feasibility with infrastructure | ICH-GCP trained staff availability | Investigator’s and sites previous experience on clinical trial | As per protocol-specific requirements and specifications
Start up documentation
Assistance in the execution of CDA, Undertaking by the Investigator Form FDA 1572, Financial Disclosure, Budgeting, Clinical Trial Agreement etc. Preparation and submission of EC dossier and follow-up on queries (if any) Development of study specific SOPs.
Preparation of site for SIV
Development of patient recruitment strategies
Development of Study management plan
Managing Logistic and operation challenges
We will ensure that all the protocol specific requirements such as trained team, equipments, calibrations and other basic infrastructure are at place by coordinating with the sponsor/CRO.
During the trial
PATIENT RECRUITMENT:
Effective recruitment is a critical factor in ensuring the success of clinical trials, as research has shown that it is responsible for up to 70% of delays in the timeline. Improving patient recruitment rates represents a significant opportunity for accelerating the clinical trial and product registration process.
To address this challenge, we leverage our local experience and in-depth understanding of the patient journey to develop effective patient recruitment strategies. This involves identifying the root causes of recruitment failure and lost follow-up and developing mitigation plans to retain patients in the study.
Our trained coordinators serve as valuable liaisons and catalysts for patient enrollment, employing various strategies approved by regulatory authorities. In addition to recruitment efforts, our coordinators work diligently to prevent patient dropouts by providing full attention and support to resolve any compliance-related difficulties during the trial.
Assist the investigator in the Patient Identification | Informed consent process, Screening and Randomization | Source documentation as per the ALCOA | Coordinate subject study visits (Scheduled / unscheduled) | Manage Clinical trial material accountability, distribution & logistics | Coordinate with Local/Central lab logistics as per the study requirement | Maintain and update trial master files | Coordinate SAE reporting on time | On time completion of Case report form | On time study related query resolution
Progress Report:
The Lifzneed team monitors site activities and produces progress reports for the specific protocol, which are regularly shared with the PI and Sponsor/CRO. This approach aids in conducting a thorough analysis and refining strategies to ensure a smoother study process.
Quality Assurance:
The integrity of data in clinical research is heavily reliant on quality assurance (QA), which plays a crucial role. According to good clinical practice, QA involves a thorough and independent review of all activities and documents related to the trial. Through audits, it is determined whether the evaluated activities were carried out appropriately and if the generated data was accurately recorded, analyzed, and reported in accordance with the protocol, standard operating procedures (SOPs), and good clinical practices (GCPs).
Post-trial:
The Lifzneed team maintains a record of site activities through progress reports specific to the protocol and provides regular updates to the PI and Sponsor/CRO. This process facilitates accurate analysis and enables the team to make necessary adjustments to improve the study's execution.
Coordinate Close out visit | Archival process and documentation | Supporting post close out audits (If in case)
Lifzneed Therapeutic Applications:
E.N.T
OPTHALMOLOGY
GENERAL MEDICINE
GENERAL SURGERY
DERMATOLOGY
DENTAL
PULMONARY MEDICINE
ANAESTHESOLOGY
OBSTERICS & GYNEACOLOGY
ENDOCRIONOLOGY
NEUROSURGERY
HIV
INFECTIONS
NEPHROLOGY
ORTHOPAEDICS
PEADITRICS
PSYCHITARY
ONCOLOGY
NEUROLOGY
CARDIOLOGY
PEDIATRIC SURGERY
GASTROENTEROLOGY
RADIOTHERAPHY
PHARMACOLOGY
MICROBIOLOGY
PATHOLOGY
Training
Lifzneed's objective is to equip medical practitioners, as well as graduates of pharmaceuticals, biotechnology, and other related fields, with fundamental research knowledge necessary for their involvement in research.
As a prominent and esteemed institution in clinical research training, Lifzneed is devoted to delivering top-notch professionals to the clinical research industry. In response to the growing demand for qualified professionals in this field, we have established a pool of talented faculty members who possess extensive experience and are dedicated to meeting the challenges of the clinical research industry's demands.
Clinical Research Co-ordinator Support:
At Lifzneed, clinical research coordinators receive comprehensive training to support the Principal Investigator in conducting clinical trials in accordance with the signed investigator statement, protocol, Standard Operating Procedures, Good Clinical Practices, and applicable international and local guidelines.
Clinical Trials Training Programme:
Overview Of Drug Development Process
Overview Of Clinical Trial Process
Clinical Trial Process
Roles & Responsibility Of Clinical Trial Personnel
Informed Consent Process
Protocol Compliance, Protocol Deviation And Violation Documentation
Essential Clinical Trial Documents
Site Master File, Managing Study Logs And Forms
SAE Management, Reporting & Regulatory Compliance
Audit Readiness
Clinical Trial Monitoring
Communication With Sponsor And CRO
Site SOPs
Exercises Etc
Foundation To GCP Guidelines
ICH-GCP Guidelines
New CT Guidelines
Indian GCP Guidelines
ICMR Guidelines
Handling Of Biological Samples
Audits & Quality Assurance
Data Management
Drug Regulatory Affairs
Ethics Committee
Good Documentation Practice, Source Documentation And CRF Filling
Site Organization & Management Of Clinical Studies
GCP Workshop
Tips To Smoothen The CRC Job