Clinical Trial Management

As the pharmaceutical companies expand their research into the next stage – clinical trials, research sees variations as per local regulations. We, at AHC act a bridge between our international client repertoire and the local regulations for conducting clinical research.

* End to End Clinical Trial Management : We offer end to end services tailor made to suit your product in research and give you the most comprehensive clinical trial, conceived, designed and conducted as per the latest national and international regulations and guidelines. 
– Our end to end services begin with documentation – medical writing as per regulatory stipulations.
– Our expert project management team is offers single point of contact between the client and AHC for query resolution and establishment of key research parameters during the course of the entire project.

* Clinical Trial Design : The clinical trial design is structured by our expert team of clinical research professionals, customised to the product in research and client requirements within the realm of national and international laws.

* Protocol Development and Clinical Trial Documentation :  Documentation services extend from drafting, finalising documents such as Clinical Study Protocol, Informed Consent Document, Patient Diary, Questionnaires, Translation of documents in vernacular language, Development of Case Report Form to collation and coordination for submission to Ethics Committee for ethical review and approval assistance.

* Investigator Selection and Site Management : Our extensive network of over 500+ investigators across India from various therapeutic specialties allows us to conduct research with ease.
– We identify and select suitable investigators and study sites based on study requirements and regulatory considerations.
– We conduct site feasibility assessment and pre-study site visits to ensure facility compliance with the requirements of the study.
– We provide complete hands-on site management support not limited to training, monitoring, data management and addressing other site related issues. 

* Project Management : We develop study timelines, budget and resource allocation plans so as to effectively conduct the study.
– We oversee project execution to ensure adherence to timelines, budgets and quality standards.
– We coordinate and communicate with all study related stakeholders periodically. 

* Patient/Subject Recruitment and Retention: We are experts at patient/subject recruitment and follow-up as our Clinical Operations team has a choice conglomeration of members from various parts of India with specialised language and cultural skill sets.
–  Our vast experience since 2008 allows us to implement several subject/volunteer retention strategies to minimise participant dropout rates and enhance study completion and quality. 

* Clinical Monitoring & Quality Assurance  : We provide expert monitoring solutions including medical monitoring. We outsource our seasoned Clinical Research Associates to provide an independent third party monitoring report of your trial site.
– We perform source data verification (SDV) and resolve data queries to maintain data integrity and compliance.

* Site Rescue Services : We present our clients in need with rescue management services for trials and research in India that needs special attention by a local body.
– Timely intervention and project management has helped many a client with trial acceleration and successful completion of their projects.
– Our expert CRA and Research Associates – Quality Assurance (Clinical Research) offer specific issue analysis and solutions, study management oversight, vendor coordination & management, co-monitoring, auditing, emergency monitoring services, medical monitoring services, data analysis and CAPA (Corrective Action Preventive Action) plans for your clinical project.

* Clinical Trial Supply Management : We provide niche services such as clinical trial supply chain management solutions, including investigational product management, led and managed by our team our pharmacists and biotechnologists.

* Data Management System : We establish data management processes well before study conduction.
– Processes such as data collection, data entry, data verification, data validation, data discrepancy management and query resolution are all performed as a ongoing periodic process during the conduct of the study to enhance quality of the data as well as effectively curb excessive time lapse during the post-conduction stage of the clinical study. 

Our CTM services cover the entire spectrum of services as mentioned and are capsulated with data management, analysis, Statistical Analysis Report and preparation of Clinical Study Report as per ICH E3 and/or other regulatory requirements.

Our indigenous origin allows us to navigate through the various local regulations with ease just as much the international scenario for drug research – in particular clinical trials.

Our Project Management team offers comprehensive research within well deserved timelines as discussed with the client. We pride on being most transparent with our client and are renowned for our confidentiality detail.

We are ISO 9001: 2015 compliant and have a vigilant Quality Assurance team comprised of individuals with exposure to clinical research auditing and keeping a quality check on the entire operations independently ensuring the quality of data over the Quality Control within the team.

All our Clinical trials are registered with Indian Council of Medical research – CTRI and World Health Organisation – ICTRP before initiation of trial conduction activities.

Our Clinical Trial Management teams ensure the best operational strategies are in place from planning and designing to delivering of the Clinical Study Report to the client. We offer regular updates of the research and follow strict Standard Operating Procedures for every activity crafted by the leading experts in India with an eye on the international scenario of Drug Research.

We offer Clinical Trial Management Services not limited to…

  • Clinical Trial Planning and Design.
  • Obtaining DCGI/Ethics Committee Approval for conduction of trial.
  • ICMR – CTRI registration process.
  • End to End Clinical Trial Services.
  • Documentation – regulated Medical Writing.
  • Comprehensive Project Management.
  • Subject Recruitment & Follow Up.
  • Expert Monitoring & Medical Monitoring Services.
  • Rescue Management Services & Trial Acceleration.
  • Clinical Trial Supply Management Solutions.
  • Investigation Product Inventory & Supply Management.
  • Data Management & Statistical Analysis.
Click Here