Unlocking Clinical Trials Success: Integrated QA Systems

[{"selector":"#anim-bc5df4e5-1246-4334-a635-9ab364ff0dfd","keyframes":{"transform":["translate3d(-118.15181%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] [{"selector":"#anim-720ea458-e0bf-41f1-94c2-7098980e4ee8","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] [{"selector":"#anim-b4fd936e-a0b9-418a-81bf-7b813107f78f","keyframes":{"transform":["scale(0.15)","scale(1)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"forwards"}]

Evolution of QA in Clinical Development

[{"selector":"#anim-906be5dd-f4d6-422e-b0c1-a4dc2d2da364","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-26e1e455-ad3f-4fa4-a8da-4df26afc7a16","keyframes":{"transform":["translate3d(-115.18988%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-35c553a7-1ec2-4f72-a15e-a1416a21b78a","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-ff4534e9-992e-40ef-82fb-cc70eaede2af","keyframes":{"transform":["translate3d(-115.18988%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}]

Intersection of QA and GCP Expectations

[{"selector":"#anim-967479c1-8d3f-44fd-bfae-290b458135b4","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-9263fbc3-e846-49ba-a682-e85e3bb40b45","keyframes":{"transform":["translate3d(-114.55696%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-2e44d111-ca7e-42eb-9cf9-86f81123d0bb","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-15aa2463-11dd-43c8-9b4a-e16b6fff1509","keyframes":{"transform":["translate3d(-114.55696%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}]

Development and Maintenance of a GCP Quality System

[{"selector":"#anim-d8c618ac-3898-428c-a055-ebfb8f6bf4a6","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-edc564de-f922-47f3-91d8-fbdf4936825f","keyframes":{"transform":["translate3d(-114.55696%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-bb702e08-89b2-46d9-86f6-d82b14eba69c","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-47de7e0f-7892-4da8-a2fd-8c7fb3e3102e","keyframes":{"transform":["translate3d(-114.55696%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}]

Quality and Compliance Oversight in Clinical Trials

[{"selector":"#anim-97f3fb87-eb99-4df4-9ce9-b1cabd94c178","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-daa75536-a5c5-405d-b553-45f80fc90491","keyframes":{"transform":["translate3d(-114.55696%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-aef49e17-5049-47ad-8640-bbdc711d4dfa","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-cbcf3a55-4120-48ba-b2d7-4bd6ccc42544","keyframes":{"transform":["translate3d(-114.55696%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}]

Third-Party Compliance and Risk Management

[{"selector":"#anim-5121f40a-ddf3-45b6-b03b-e6261b2c6af9","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-6ba3e930-029e-49e5-bc38-fc8de882b5a8","keyframes":{"transform":["translate3d(-115.18988%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-bcc551a5-e5ef-4a61-86e2-2e1cb19548c8","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}] [{"selector":"#anim-19a989f7-5b7e-4718-bafd-1391131dccc9","keyframes":{"transform":["translate3d(-114.55696%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.2, 0.6, 0.0, 1)","fill":"both"}]

Unlocking Clinical Trials Success: Integrated QA Systems

[{"selector":"#anim-2515c473-8bc0-450b-b839-75d7da630f97","keyframes":{"opacity":[0,1]},"delay":0,"duration":2000,"easing":"cubic-bezier(.3,0,.55,1)","fill":"both"}] [{"selector":"#anim-19d9cc05-ad07-4585-a035-99cca2f87f22","keyframes":{"transform":["scale(0.3333333333333333)","scale(1)"]},"delay":0,"duration":2000,"easing":"cubic-bezier(.3,0,.55,1)","fill":"forwards"}] [{"selector":"#anim-ebb3ec11-cbe2-4c2a-a2f7-5649049ef300","keyframes":{"transform":["translate3d(-127.03704%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":1000,"easing":"cubic-bezier(.2, 0, .8, 1)","fill":"both"}] [{"selector":"#anim-36c8fbee-a2e1-4f78-bdf1-41733c3fde26","keyframes":{"transform":["rotateZ(-180deg)","rotateZ(0deg)"]},"delay":0,"duration":1000,"easing":"cubic-bezier(.2, 0, .5, 1)","fill":"forwards"}] [{"selector":"#anim-34777f79-5a0e-4b7a-a3ea-01fbc6641d24","keyframes":{"transform":["translate3d(-117.82179%, 0px, 0)","translate3d(0px, 0px, 0)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] [{"selector":"#anim-349ddb22-36ab-4f86-ba0f-5fe97f7b9379","keyframes":{"opacity":[0,1]},"delay":0,"duration":600,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"both"}] [{"selector":"#anim-125e22cd-da2c-429d-bea1-ede5e7252a68","keyframes":{"transform":["scale(0.15)","scale(1)"]},"delay":0,"duration":600,"easing":"cubic-bezier(0.4, 0.4, 0.0, 1)","fill":"forwards"}]

Unlocking Clinical Trials Success: Integrated QA Systems

Evolution of QA in Clinical Development

QA's evolved role ensures regulatory compliance and aligns with business strategy for seamless clinical study execution.

Intersection of QA and GCP Expectations

Synergy between QA and GCP enhances study execution, ensuring better data and smoother FDA approval.

Development and Maintenance of a GCP Quality System

An integrated GCP QA unit adds value with metrics, aligning quality management with business goals for excellent study execution.

Quality and Compliance Oversight in Clinical Trials

QA's pivotal role includes overseeing GCP activities, ensuring document compliance, and acting as a prevention-focused quality engineer.

Third-Party Compliance and Risk Management

QA establishes third-party supplier management, develops risk management plans, and ensures periodic reviews for critical quality and compliance risks.

Unlocking Clinical Trials Success: Integrated QA Systems