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Our expert teams work closely with the sponsors to arrive at the best solutions for each project and deliver clinical trials of the highest quality, with compliance. ALH offers the full range of clinical trial implementation services across India, with a successful record of fulfilling regulatory requirements.
Our expert teams work closely with the sponsors to arrive at the best solutions for each project and deliver clinical trials of the highest quality, with compliance. ALH offers the full range of clinical trial implementation services across India, with a successful record of fulfilling regulatory requirements.
Our highly experienced, locally-based teams allow us to deliver flexible and innovative solutions to accessing patient populations, and ensure that our clinical trials make a lasting impact on sponsors, clinicians and patients.
Our highly experienced, locally-based teams allow us to deliver flexible and innovative solutions to accessing patient populations, and ensure that our clinical trials make a lasting impact on sponsors, clinicians and patients.
Site Selection
Site Selection
Site feasibility
Site selection
Protocol design
Protocol design
Site Management
Site Management
Site setup
Site Initiation
Subject recruitment
Subject retention
Training
Project Management
Project Management
ALH has accomplished project management teams to oversee all the functional areas and vendors across the lifecycle of a trial. ALH project managers are allocated seasoned staff members, including a team of regionally-based CRAs. For a full-service study, our project managers will lead delivery across our functional expertise, including:
Data management
Statistics
Endpoint management
Medical monitoring
Medical writing
ALH project managers are responsible for ensuring clear communication among all stakeholders, particularly with our sponsors. Our project managers are the central point of coordination for all tracking and reporting on behalf of the study team.
Clinical Trial Monitoring
Clinical Trial Monitoring
Critical to a successful clinical trial is the efficient management and monitoring of clinical sites. ALH engages a diverse range of specialized staff to this end. Clinical Trial Monitoring activities and services include:
Full service monitor visits – qualification, initiation, routine, and close-out
Comprehensive monitoring plans
In-country expertise for feasibility or regulatory submissions
Thorough review of site records
Timely completion of visit reports
Quality review of monitor reports
Source document verification as per monitoring plans
Rapid query resolution
Site training and support
Site management support and documentation
Periodic remote EDC review
Drug accountability
Data Management
Data Management
Statistics
Statistics
Project Monitoring
Project Monitoring
Onsite activities
Off-site activities
Medical Monitoring
Medical Monitoring
Medical Writing
Medical Writing
The quality of written clinical presentations plays a vital role in the success or failure of new compounds and devices. At ALH, we provide help in developing a wide range of medical or scientific documentation. The scope of our services includes:
Study protocols and reports
Abstracts, manuscripts and journal articles
Investigator brochures and annual updates
Informed consent
Pre-clinical study reports, expert reports and summaries
Preparing CRF
Regulatory Services
Regulatory Services
Our team comprises of veteran regulatory and safety professionals with the knowledge (including local language and culture) and contacts needed to communicate effectively with the appropriate regulatory authorities.
Our service provision is flexible and can be structured to best fit our sponsor’s needs. Such services include:
Guidance in AYUSH Licensing documentation
Guidance in FSSAI license related documentation
Technical datasheets of botanical ingredients
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