Clinical Operation

Clinical Operation

1. STUDY START-UP

 

With its expertise, HMC will help make your tests a success. We'll work out effective participantsign-up strategies, quick processes, and efficient venue selection to make your trial go as fast as possible with minimal to no complications.

 

Our top criteria is to: sSaveing time and costs but still ensureing efficiency in the workflow is our top criterion in the process of building workflow. With decades of working experience, HMC ensures the testing process alwaysgoesruns on andahead ofschedule, whileminimizinging any potential risks. Hereis oOur system of focus points to-gives you an overview of your startup:

● Evidence-based feasibility

● Carefully evaluated and sSelected position

● Identify and evaluate potential bottlenecks to create effective risk reduction strategies

● Clinical trial validation and legal documentation

● Collect and review site management documents

● Procurement of regulatory and/or ethics committee approvals

● Organize and hold investigator meetings

● Website initialization and rapid audience recruitment

 

2. CLINICAL MONITORING

Your test will be a great success under our CRA monitoring team. HMC's CRA experts are always ready to go toavailable at the test site for monitoring, wherever it takes place. All activities follow ICH GCP process, research protocol, monitoring plan and client's expectations. We will continuously update information, reviews and support 24/7.

What we offer our partners:

● Visits start the site

● PeriodicFrequent site monitoring visits

● Site management and easy access- including regular site contact via phone, email, etc.

● Monitor the query resolution process

● Website support during database locking

● Research observational visits

If you need more than that pointthe points listed above, that's okay,HMC has a custom service that ensures a good fit. Contact us now..

 

3. SITE MANAGEMENT

You need professional site management to make the trial process efficient and get results quickly.

 

HMC's CRA is highly trained and available 24/7. We are adept at building long-term partnerships with investigators and supporting effective trial recruitment, as well as ensuring consistent data quality and consistency.

The thingsResources and tools that HMC offers you during your studies are:

● Training and educating site staff

● Research intoofdrug and non-drug supply logistics

● Keeping track of regulatory document revisions

● Monitoring protocol deviations

● Subject state tracking in trials

 

4. SAFETY MONITORING

 

Keeping patient safety and reducing risk should always be the firsta priority.

 

In our staff development strategy, there are always safety and therapy areas and pieces of training. HMC medical monitors are available 24/7.

 

In our staff development strategy,we provide safety areas as well as therapy options for our training.HMC medical monitors are available 24/7.

 

Strategic services that HMC provides:

● PlanMmedical supervision planning

● Performance of medical surveillance  ofinclusion/exclusion criteria

● Therapy area training for CRA and PM

● Assistance in SAE (Serious Adverse Event) reportsing to investigators

● Interactioning with the Data Safety Monitoring Board (DSMB)

● Distribution ofing secure information reasonably among investigators

● Announce sSafety notice to toregulatory authorities and/or ethics committee

 

5. CLINICAL TRIAL LOGISTICS

To make your trial go smoothly, our clinical trial logistics will:

● Apply for import and export permits from regulatory agencies

● Prepare customs documents

● Import of research products, comparators, and research materials, including laboratory kits and any specific equipment

● Store, distribute, relabel, return, and destroy investigative materials/equipment.

● Export biological samples from clinical sites to the central laboratory

● Management of courier services

With industry-leading experts and extensive relationships, we always support you wholeheartedly.

 

6. VENDORS' MANAGEMENT

YouIf youfind it too complicateddifficultto understand the risks, relationships, or other policies in connection with laboratories and warehouses,. tThen simplify things by working with HMC. We have strong relationships with all parties: quality assurance, advanced technology, and full certifications. The associates of HMC have always been reputable in clinical trials and enthusiastic support at all times.


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Headquarters

5 Penn Plaza, 19th Floor, New York, New York, 10001, United States of America

Contact Us

800 320-1438 HomerWu@HopkinsMedtech.com

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