患者様リクルートの「漏れるファネル」を補修:データと患者様・施設中心のアプローチを統合して課題を克服

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この業界では、ほとんどの人が「漏れるファネル」のことを知っています。この言葉は、治験で大勢の患者様に呼びかけつつ、その過程で人数がどんどん減っていくことを示します。計画やスクリーニング、試験のなかで患者様を失えば、コストがかかるだけでなく大幅な遅れにもなり、有効な治験の成功までもが脅かされかねません。

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4 Tips to Manage Your Inbox like a Project Manager

Covance employees in the regional study coordinator (RSC), or associate project manager, role within our Global Project Management Department receive extensive training before managing the day-to-day activities of a clinical trial at a regional level.

Managing local laboratory operations and serving as the bridge between our internal departments and various clinical studies, RSCs must manage competing interests and communicate and articulate critical information to each department and amongst the project management team.

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K-REACH 規則下での登録方法:12 の簡単なステップ

In 2015, South Korea introduced legislation designed to protect human health and the environment from the impact of chemicals. With an estimated 44,000 chemicals in use in South Korea and about 300 new chemicals marketed annually, registrants and regulators will be kept busy assessing the risk posed to humans, animals and the environment. This legislation was revised to impose stricter controls on a broader range of substances, effective January 1, 2019.

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COVID-19 の渦中で:償還受付コールセンターの機敏な対応の重要性

The impact of COVID-19 on reimbursement call center operations has the potential to be significant. However, a proactive crisis management plan and a dispersed, redundant operating model can go a long way towards safeguarding your patient support programs. As governments and citizens address challenges posed by this global pandemic, many companies are limiting in-office operations, or closing them entirely. Now is a good time to evaluate your current and future reimbursement call center strategy and be as prepared as possible for the unexpected events that interrupt patient access to your therapies.

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あなたもその 33% の一人?米国腎臓財団のサポート

They are not something most of us think about, that is, until something goes wrong. They filter 53 gallons of blood per day, remove toxins and excess volume from your blood, and help control other things like blood pressure and hemoglobin counts. They are our kidneys: two fist-sized bean-shaped organs that keep you healthy by making sure your blood remains in metabolic balance. Once a patient approaches kidney failure, we hope to get them a kidney transplant, but the reality is that the majority of patients undergo dialysis simply because there are not enough donated kidneys to go around. Either dialysis or a kidney transplant is needed to survive once kidney function is so poor that it needs replacement therapy.

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工業用化学品の環境動態研究を成功させるには

Environmental fate (eFate) studies are well established for crop protection chemicals and pharmaceuticals and are becoming commonplace for industrial chemicals, but what are the key considerations for setting up and running them? それでは一体どうすればよいのでしょうか?

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まもなく導入されるコンビネーション製品承認申請時のレポーティング要件の準備は万全ですか?

Combination Products: What are they?

Any product formed from the combination of a drug, a device and a biologic is referred to as a combination product.  Under 21 CFR 3.2 (e) this includes two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity.

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Advancing Innovations in Early Stage Oncology Research: Meet Amy

Many novel oncology treatments have brought new hope to people living with cancer, but these breakthrough medicines weren't developed overnight. On average, it takes at least 10 years to create a treatment "from molecule to medicine."

As a Study Director at Covance, Amy supports a key part of this process by helping pharmaceutical and biotech companies thoroughly evaluate their oncology drug candidates at the early stages.

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実は希少ではない希少疾患

ALS の研究を支援するアイスバケツチャレンジや、嚢胞性線維症、筋ジストロフィーなどの患者様を応援するウォーキング、マラソン、24 時間テレビなど、有名な募金イベントが開催されている疾病もあります。一方でウィルソン病(体内で銅が過剰に蓄積される稀な疾患)などは、身近な友人や家族以外にはほとんど知られていません。支援団体の Global Genes によれば、総合すると、明確に区別できる希少疾病は 7,000 種類もあり、世界で最大 4 億人が苦しんでいるのです。希少疾患と診断された患者様のうち約半数は子供です。

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植物保護製品の承認更新について -  EU の規制

ヨーロッパでは、単一市場への PPP(植物保護製品)投入に関する法律が規則 (EC) No. 1107/2009 に定められており、そのなかの AS と PPP に関する特定のデータ要件は規則 (EU) No. 283/2013 と No. 284/2013 記されています。AS の承認は通常 10 年で失効します。PPP を継続的に販売するには、AS の承認を更新する必要があります。更新の手順は欧州委員会実施規則 (EU) No. 844/2012 に規定されており、ヨーロッパレベルの手続きとなります。

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アフリカ系アメリカ人月間によせて:コーヴァンスのコミュニティ構築に貢献した人物をご紹介

全米アフリカ系アメリカ人 / 黒人月間は、社会に変化をもたらしたアフリカ系アメリカ人の功績を讃えます。 数多くの著名なアフリカ系アメリカ人の医師、エンジニア、科学者、看護師が医療や科学の進歩に貢献し、STEM(科学、技術、工学、数学)分野でのキャリアを目指す有色人種の学生たちの手本として活躍し続けてきました。   

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