Site Network and Site Management

We understand that selecting the right investigators and sites to run trial is a critical success factor, which directly impacts enrollment, patient retention, data integrity, study timelines and cost.

Hence, Amclin provides sites with investigators and site staff who are not only qualified and experienced with excellent record of patient enrollment and quality but also passionate about clinical trials.

We believe that a passionate team can achieve exceptional result consistently, irrespective of the challenges.

Amclin Study Coordinator and clinical Managers as well as Investigators maintains a close knit relationship with patients, resulting in patient retention thus making sure that the study objective/ endpoint is not affected by missed visits, early withdrawal or lost to follow up.

Key differentiators 

  1. Study startup & Patient recruitment: Investigator & Patient’s database: Amclin has a distinctive network of investigators and patients who are actively seeking new trial opportunities. We leverage this exclusive resource to identify sites that are ideal matches for each protocol and have the best chance for success. Thus making sure that the study start up timelines are the shortest and you get a boost in recruitment with pre-identified pool of willing patients.

We always keep a patient centric approach and truly understand that it’s the wheel which sets the whole clinical trial activities in motion at site.

  1. Centralized study management: The study management is done using our innovative cloud-based CTMS. This clinical trial enhancement system used at our sites transforms the quality and effectiveness of trial management.

It serves as a single source of truth and provide real time visibility & status throughout the life cycle of a project.

It is a solution for precision feasibility, project startup, execution and close out as well as document management and

Trainings.

Our technology replaces inefficient Excel, email and paper-based processes with automated trackers and solutions

that bring trial stakeholders together.

  1. Metrics driven: The below Metrics is the benchmark we have set for ourselves and we incessantly strive to live by it.
  1. Feasibility response- within 5 days of receipt of feasibility request/form
  2. Startup timeline: SPOC for contracts execution & within 7 days of term agreements
  3. First Patient In (FPI) Timelines: We know how critical is the first patient to start the ball rolling at site < 15 days OR can be company metrics
  4. Patient Recruitment- Meet target >90% studies conducted till date
  5. SDV entry- within 48 hrs. of subject study visits
  6. Data Quality- <5 PDs , zero major audit findings per study
  7. Database closure- 100% of studies within time
  1. Trained & adequate resources: GCP and regulations trained PI, CRCs, Clinical Managers as well as Internal Medical expert.

Sites with SOPs in action,

Yearly refresher GCP trainings & case study oriented training for site staffs on a regular basis.

  1. Communication: We know many studies where lack of timely communication has been one of the reason for unsuccessful trial. Hence at Amclin, we clearly define the communication and escalation strategy that will be followed at our site.

eg: SPOC for Project communication with sponsor/CRO, Weekly study reports, etc.

Site Management: We also provide trained and highly experienced CRCs for trial management to sponsors & sites. Our CRCs assist the investigator and site staff with all day-to-day study activities. We employ our systems for study management even at non-networked sites, which makes sure that we are always on top of the study.

The roles and responsibility of CRC includes:

  • Ensuring accurate of data
  • Site preparation for the clinical trial
  • EC Correspondence
  • Additional staff training
  • Interacting with all stakeholders- Site personnel’s, CRO, Labs & Sponsor.
  • Maintaining clinical trial documents/records
  • IP storage and accountability
  • Scheduling patients’ visits and ensuring retention till study completion
  • Providing weekly study status report to investigators.

With Amclin’s study management tools and trained personnel’s you will be not be surprised to find the following result at our sites:

Increase in patient recruitment

Reduction in protocol deviations

Reduction in Data queries

Reduction in overall trial cost