パンデミックによるウイルス感染のリスクを軽減するために、弊社は早期フェーズの施設とプロセスを適応させました。弊社の各ユニットはCOVID-19関連の製品開発をサポートすることができます。パンデミックを終息させるためには一刻の猶予も許されないため、柔軟なキャパシティモデルと分散型臨床試験プロセスを可能な限り導入しています。
フェーズ Ⅰ - Ⅱ 試験を迅速に進めて概念実証を達成することは、戦略上の重要なマイルストーンとなります。それはアンメットニーズのある患者さんにとって、希望の持てる重要な目標地点でもあります。パレクセルでは患者さんにより早く希望を届けられるように早期臨床試験をデザインしています。
弊社の80人以上の元規制担当者は、規制当局の視点から見た早期フェーズの遅れの主な原因を熟知しています。これらの原因には投与量の不適切な科学的正当性、安全性のしきい値の不一致、試験デザインの問題などがあります。
パレクセルはこれらのリスクを軽減するための専門知識を有しています。規制、薬理学、トランスレーショナル・メディスンの専門家からなる統合チームを結成し、薬剤の投与量、安全性の選択、PK/PDの評価について情報を提供します。私たちは意思決定に必要なデータを得るために、お客様がより効果的かつスマートに機能するプロトコルの設計を支援します。
また早期フェーズ試験を開始する際には、早期フェーズ臨床試験を行うクリニックのグローバルネットワークが、あらゆるサービスを提供します。
サービスには以下のものがあります:
Learn how to participate in a clinical trial and discover how you can help greatly improve lives worldwide for decades to come.
"私は微力ながら医学の未来に貢献することをしています。" -シモンさん(ボランティア参加者)。世界中の患者さんに効果のある治療法を開発するために、あなたがどのように貢献できるかをご紹介します。
Simon:
There's lots of illnesses out there that we still don't have cures for. So without trials, we're going nowhere.
Gillian:
My experience participating on the clinical trials that I've been on, it's been really good. I think the staff were just so professional, and warm, and welcoming.
Amanda:
We're all in it as one big team who are looking to further the development of new medicines for those diseases that ultimately improve the quality of life of individuals.
Simon:
I'm doing something in a small way that's beneficial to the future of modern medicine.
Lorenzo:
I've most probably participated in about 30 trials over a 20 year period. The main thing I like about doing clinical trials is you're away from the everyday, and take part in a trial which obviously helps in clinical research.
Benjamin:
You got time to watch films and use the recreation room, and meet new people, as well, which I thought was really good, just to interact with other people from different walks of life.
Abdul:
One of the things that I like working for Parexel is the interactions that I have with the volunteers. I make sure I just make them feel welcome, like home.
Wilma:
I have a very good relationship with the volunteers. We laugh, we joke.
Bartosz:
I usually find out about medical trials by calling in. There's also websites that I've been using quite often to find out if there's anything going on.
Amanda:
So we can also reach out to our volunteers and patients via a Facebook page that we have, and also Instagram. Some of our patients and volunteers prefer to be contacted by text messaging, as well.
Jackie:
When you come into the unit, the staff really welcome you. If you're new, they'll go through everything step by step.
Daniel:
I come to the clinic and see if the volunteers are okay. I'll answer any questions that they might have, also.
Haseeb:
The thing that makes me keep on coming back here, by far, is definitely the staff. They are very friendly, they always make you feel comfortable.
Radomira:
It's really nice to have new people. We tell them what we need from them. They tell us if they have any concerns. We try to bring them on so they're part of the team.
Alexander:
I think it's very important that people participate in clinical trials because it's the origins of medicine.
Suresh:
The healthy volunteers and patients who are participating in the trial are the backbone for the drug development. Their contribution of their time is crucial for the world.
Elaine:
When you think about the amount of things that we haven't even found a cure for, this is just a stepping stone towards that. It has to make a difference, is what I always feel. Even if it's one person, then that's the best thing.
We are always available for a conversation.