Sponsors

CRO’S Collaborations with Pulse

Pulse Clinical Research

Pulse Clinical Research recognizes that the accurate identification of potential study sites is critical to the overall success of any clinical trial. The Pulse Clinical Research operations team has a great deal of experience in identifying investigators as well as evaluating site staff, facilities, clinical research expertise and patient demographics. Pulse Clinical Research provides services in all related spheres to support our client′s Clinical trial processes. The services are customized to our client′s requirements. We look to enable our clients to perform to their best potential. We help them to streamline their activities and extend their geographic coverage in order to capitalize on their products as swiftly and effectively as possible in the marketplace.

We achieve this through our:

  • Network of experienced physicians and coordinators across India, which is continuously expanding.
  • Excellence in Onsite Coordination and Monitoring of Pre trial, during the trial, post clinical trials.
  • Leadership and management expertise necessary to produce consistent and statistically sound data for every study conducted.
  • Multiple Therapeutic Segments.
  • Streamlined and expeditious start-up and completion of studies on schedule.
  • Quality source documentation, case report forms and other paperwork.

And in addition to this :

  • Identify sites
  • Identify Principal Investigators
  • Conducts Feasibilities
  • Identify and coordinate translations of Essential documents
  • Identify Couriers and other support service vendors
  • Regulatory submission & approval with rapid turn-around time
  • Site set up
  • Document collection
  • Create source document template
  • Prepare site for SIV
  • Pre-screening, in case of chronic disease trials
  • Assist in the ICF process, screening & enrollment
  • oordinate subject follow up visits preventing lost to follow up & missed visits
  • Manage CTM accountability, distribution & logistics
  • Coordinate Central Lab logistics & sample flow
  • Coordinate Monitoring & Audit visits
  • Subject reimbursements
  • Maintain and update Trial Master File
  • Coordinate SAE reporting on time
  • Communicate with EC for submissions of essential documents during the study
  • Post Trial
  • Coordinate close out visit
  • Resolve data queries
  • Archival documents at site

Pulse Clinical Research strength in site identification is evaluating the protocol, patient population and available resources in order to develop strategies that will help ensure that only the best locations and sites are presented to our clients for evaluation.

In order to help build a strong foundation for site selection recommendations, Pulse Clinical Research will utilize and evaluate its existing network database nearly 100 investigators and physicians practicing and conducting research throughout India, as well as data on over 80 research sites. Using robust databases made up of epidemiology information and patient demographics from hospitals, Pulse Clinical Research will identify the geographic areas and investigative sites that have the highest prevalence of patients suffering from any one of over 600 conditions.

Pulse Clinical Research will then overlay that prevalence data with our database of investigators to identify those physicians working within areas of highest prevalence; seeing the most patients annually for a specific condition, as well as those having the greatest clinical trial experience, or capable of becoming successful investigators. This level of data is important as research has shown that sites in patient-rich zones have higher net randomization rates.

  • We have a broader data base of the various sites, which enables to select the site which are more relevant to the protocol.
  • We select the site with maximum care so that projected enrollments and data quality can be met.
  • Our organization provides site co-coordinators to manage the day to day activities at the site.
  • Our co-coordinators are having vast potentiality to make the site different from the others.
  • Our co-coordinators are well versed to full fill timely requirements of regulatory authorities.
  • Our co-coordinators are well versed with the local language for recruitment assistance & retention of the subjects.
We routinely supervise the progress of clinical trial and manage the funds strictly according to the financial agreement among the clients looking the Indian scenario.

We are specialist in handling of Investigational Product(s) and other trial related supplies at site.

We are disciplined to obey the international guidelines (ICH-GCP) and it is in our habit to keep the trial according to the expectations of international & their own national regulatory requirements.

Our trained co-coordinators make the good liaisons and work as a catalyst to enroll the subjects by various strategies permissible by regulatory authorities. Not only enrollment but our co-coordinators do their best efforts to stop the drop-out by the subjects from the study by paying the full attention and by solving their difficulties in compliance of trial.

Queries resolved on priority basis whether these are from sponsor or from the investigator site. The early resolution of queries always helps the all sides to generate the clean & legible data.