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Address
920 Aspen Court, Boston
Clinic Hours:
9:00am – 5:00pm (Mon-Fri)
Clinic Number
(857)-200-1031
Emergencies:
(617)-350-2714
Menu
920 Aspen Court, Boston
9:00am – 5:00pm (Mon-Fri)
(857)-200-1031
(617)-350-2714
Please check some of our selected the projects and unique value we bring to our clients for our Regulatory Affairs and Clinical Study services here.
Requalite successfully conducted one of the firsts COVID diagnostic clinical study in Germany as per new IVDR. The study involves about 1300 prospective samples of which swabs were collected from oropharyngeal, nasopharyngeal, and sputum specimens. The study compared the performance of the PCR kit with another CE marked device in terms of diagnostic sensitivity and diagnostic specificity. The study was conducted in a duration of 5 months in Germany in multi-sites. Requalite has effectively coordinated the study and communicated with local and federal authorities in coordination with the clinics, test laboratories, doctors, and the Sponsor of the study. The study is conducted as per GCP-ICH, Helsinki Protocol, EU IVDR, local and federal regulations. The study was conducted with approval of local ethics committee and the BfArM.
Requalite is proud to conduct one of the firsts diagnostic clinical study in Europe for recently developed disease of Monkeypox. The study involves more than 500 patient samples in multi-center study sites in Germany. This unique study also include sequencing, and cultivation of the specimens to develop a sound scientific study design in regulatory compliance globally. The study includes a subject PCR device, compared to a CE marked comparator kit in terms of diagnostic sensitivity and specificity performance parameters. The study is conducted as per GCP-ICH, Helsinki Protocol, EU IVDR, local and federal regulations. The study was conducted with approval of local ethics committee and the PEI.
Requalite has successfully conducted multi studies of a PCR assay and automated instrument for highly infectious diseases of HIV, HBV, and HCV. The studies were conducted using retrospective blood samples collected from all over Germany and tested in a centralized Lab. The PCR device performances were compared to a CE marked fully automated and well-known device using the performance parameters of Diagnostic sensitivity and diagnostic specificity. The study was conducted as per IVDD regulations. All three studies were conducted within 5 months including ethics committee applications and approval.
Requalite provided a full regulatory support to a fast growing Medical Startup to prepare the documentation, reports, and technical files in compliance with EU IVDR provisions. The complex device also contain a software element to consider for regulatory application. In this model, Requalite also provided Quality management (QMS), Risk management, Post-market Surveillance help to its Startup client where they lack of resources. With this approach The Client was fully supported with several experts from different departments from Requalite, therefore the client has overcame the shortage of the personnel, know how, and time strains.
Patient Coordinator
Practice Manager
Senior Medical Assistant
Nurse Practitioner
Requalite successfully conducted one of the firsts COVID diagnostic clinical study in Germany as per new IVDR. The study involves about 1300 prospective samples of which swabs were collected from oropharyngeal, nasopharyngeal, and sputum specimens. The study compared the performance of the PCR kit with another CE marked device in terms of diagnostic sensitivity and diagnostic specificity. The study was conducted in a duration of 5 months in Germany in multi-sites. Requalite has effectively coordinated the study and communicated with local and federal authorities in coordination with the clinics, test laboratories, doctors, and the Sponsor of the study. The study is conducted as per GCP-ICH, Helsinki Protocol, EU IVDR, local and federal regulations. The study was conducted with approval of local ethics committee and the BfArM.
Requalite is proud to conduct one of the firsts diagnostic clinical study in Europe for recently developed disease of Monkeypox. The study involves more than 500 patient samples in multi-center study sites in Germany. This unique study also include sequencing, and cultivation of the specimens to develop a sound scientific study design in regulatory compliance globally. The study includes a subject PCR device, compared to a CE marked comparator kit in terms of diagnostic sensitivity and specificity performance parameters. The study is conducted as per GCP-ICH, Helsinki Protocol, EU IVDR, local and federal regulations. The study was conducted with approval of local ethics committee and the PEI.
Requalite has successfully conducted multi studies of a PCR assay and automated instrument for highly infectious diseases of HIV, HBV, and HCV. The studies were conducted using retrospective blood samples collected from all over Germany and tested in a centralized Lab. The PCR device performances were compared to a CE marked fully automated and well-known device using the performance parameters of Diagnostic sensitivity and diagnostic specificity. The study was conducted as per IVDD regulations. All three studies were conducted within 5 months including ethics committee applications and approval.
Requalite provided a full regulatory support to a fast growing Medical Startup to prepare the documentation, reports, and technical files in compliance with EU IVDR provisions. The complex device also contain a software element to consider for regulatory application. In this model, Requalite also provided Quality management (QMS), Risk management, Post-market Surveillance help to its Startup client where they lack of resources. With this approach The Client was fully supported with several experts from different departments from Requalite, therefore the client has overcame the shortage of the personnel, know how, and time strains.
Requalite successfully conducted one of the firsts COVID diagnostic clinical study in Germany as per new IVDR. The study involves about 1300 prospective samples of which swabs were collected from oropharyngeal, nasopharyngeal, and sputum specimens. The study compared the performance of the PCR kit with another CE marked device in terms of diagnostic sensitivity and diagnostic specificity. The study was conducted in a duration of 5 months in Germany in multi-sites. Requalite has effectively coordinated the study and communicated with local and federal authorities in coordination with the clinics, test laboratories, doctors, and the Sponsor of the study. The study is conducted as per GCP-ICH, Helsinki Protocol, EU IVDR, local and federal regulations. The study was conducted with approval of local ethics committee and the BfArM.
Requalite is proud to conduct one of the firsts diagnostic clinical study in Europe for recently developed disease of Monkeypox. The study involves more than 500 patient samples in multi-center study sites in Germany. This unique study also include sequencing, and cultivation of the specimens to develop a sound scientific study design in regulatory compliance globally. The study includes a subject PCR device, compared to a CE marked comparator kit in terms of diagnostic sensitivity and specificity performance parameters. The study is conducted as per GCP-ICH, Helsinki Protocol, EU IVDR, local and federal regulations. The study was conducted with approval of local ethics committee and the PEI.
Requalite has successfully conducted multi studies of a PCR assay and automated instrument for highly infectious diseases of HIV, HBV, and HCV. The studies were conducted using retrospective blood samples collected from all over Germany and tested in a centralized Lab. The PCR device performances were compared to a CE marked fully automated and well-known device using the performance parameters of Diagnostic sensitivity and diagnostic specificity. The study was conducted as per IVDD regulations. All three studies were conducted within 5 months including ethics committee applications and approval.
Requalite provided a full regulatory support to a fast growing Medical Startup to prepare the documentation, reports, and technical files in compliance with EU IVDR provisions. The complex device also contain a software element to consider for regulatory application. In this model, Requalite also provided Quality management (QMS), Risk management, Post-market Surveillance help to its Startup client where they lack of resources. With this approach The Client was fully supported with several experts from different departments from Requalite, therefore the client has overcame the shortage of the personnel, know how, and time strains.
